By Karla L. Palmer –
The GAO was asked to review DEA registrants’ and others’ interactions with DEA. The GAO Report, released at the end of July examines the following: (1) To what extent registrants interact with DEA about their Controlled Substances Act (CSA) responsibilities and registrants’ perspectives on those interactions; (2) how state agencies and national associations interact with DEA; and, (3) stakeholders’ perspectives on how DEA enforcement actions have affected prescription drug abuse, diversion, and access to drugs for legitimate medical needs. To conduct its study, GAO administered web-based surveys to DEA-registered pharmacies, distributors, corporate offices of chain pharmacies, and practitioners. GAO interviewed DEA employees, individuals from 26 national associations including non-profit associations, and 16 government agencies in four states. Set forth below are some of the GAO’s conclusions.
Registrants’ Interactions with DEA. The Report notes that registrants vary in the extent of their interaction with DEA, and their awareness of DEA resources available to assist registrants in complying with the CSA and DEA’s implementing regulations. Page 19 of the Report notes that although DEA has made available various resources to assist registrants, such as guidance manuals and registration validation tools, registrants are not utilizing these resources because they are unaware they exist. (Report at 20). Registrants also want DEA to provide them with additional information. GAO indicated that distributors may have more communication with DEA given the fact that their renewal cycle is on an annual basis, while pharmacies and practitioners renew their DEA registrations every three-years, and are not subject to scheduled, cyclical regulatory investigations. Report at 17 (... although we note that DEA has been inspecting pharmacies on a more frequent basis than it did in the past).
The survey also showed that many registrants are not utilizing these DEA information resources. For example 70% of practitioners are not aware of the Practitioner’s Manual, and 53 percent of pharmacies are not aware of the Pharmacist’s Manual. Although the survey interestingly refers to “Know Your Customer” guidance for distributors, that information is not generally available, to our knowledge, on DEA’s website or otherwise; instead DEA provides the “Know Your Customer” guidance to distributors when it visits the registered location or otherwise meets with the registrant. GAO states that the “lack of awareness among registrants of DEA resources and conferences suggests that DEA may not have an adequate means of communicating with its registrant populations.” Report at 21.
The GAO also noted, surprisingly, that while DEA has promoted some industry conferences by email, DEA generally does not have current, valid email addresses for all of its registrants. GAO stated that DEA should “ensure that there are adequate means of communicating with stakeholders who may have a significant impact on the agency achieving its goals.” Report at 22. DEA officials responded that despite the lack of awareness noted by GAO, DEA indicated that they do not believe they need to “take any additional steps to improve communication or raise registrants’ awareness of the agency’s conferences and resources.” Id.
GAO concluded that given the state of industry unawareness of available resources, DEA “lacks assurances that registrants have sufficient information to understand and meet their CSA responsibilities.” Among the registrant groups that communicate with DEA, a common theme contained in the responses to the GAO survey was that they desired more and clearer communications from the Agency, as well as a more collaborative and proactive relationship. Pharmacies and distributers responded in particular that they wanted increased guidance and communications with the Agency.
Although State Agencies are Satisfied, Associations Want Improved Communications with the Agency. GAO described different communications that state agencies had with DEA, such as through joint enforcement activities, joint task forces, or otherwise working collaboratively to reduce diversion and abuse. State agencies reported general satisfaction with interactions with the Agency. However, twenty four national associations reported various levels of interactions with DEA, typically through meetings where they have hosted DEA at events to discuss regulations or trend data on prescription drug abuse.
Some associations noted that DEA interactions were insufficient in terms of both communication and collaboration. Five reported that as prescription drug abuse has increased, DEA has been less collaborative; officials from two organizations noted that DEA refused to meet with them to clarify issues related to their members’ CSA responsibilities. Report at 35. DEA responded that registrants should communicate directly with DEA to the extent they have questions related to “roles and responsibilities.” GAO noted that improved communications with and guidance for registrants may address associations’ concerns.
DEA’s Enforcement Actions may have Decreased Diversion and Abuse but Also May Have Limited Legitimate Access to Controlled Substances. Many of the survey responders reported that DEA’s actions have resulted in decreased drug abuse and diversion. However, over half of DEA registrants reported changing certain business practices as a result of DEA enforcement actions, or the business climate the actions have created. Many reported these changes limit access to prescription drugs for patients with legitimate medical needs.
As for enforcement actions, GAO reports that many stakeholders believe that the Agency’s enforcement actions have helped to decrease drug diversion and prescription drug abuse. A review of DEA enforcement actions from 2009 through 2013 showed that certain types of administrative enforcement actions -- enforcement hearings, letters of admonition, and memoranda of agreement – increased across all registrant types. However, other administrative enforcement actions including orders to show cause and immediate suspension orders decreased. This shows that DEA’s enforcement efforts are being resolved by methods that involve increased cooperation between registrants and DEA. However, there is no available data to show the link between DEA enforcement actions and a decrease in diversion. Report at 38.
GAO recognized that some changes in business practices may help drug abuse and diversion, and cited specifically to pharmacy calls to verify prescriber prescriptions. The Report noted, though, that stricter distributor thresholds, or limits on the quantity of controlled substance ordering, which were influenced by DEA’s enforcement actions against distributors, limit supplies of controlled substances to those with legitimate medical needs. Of the national associations interviewed, more than half expressed concern that DEA’s enforcement actions have limited access to controlled substances that serve legitimate needs. DEA responded that enforcement actions do not have any bearing on access issues, and they have rarely heard about concerns with patient access to needed medications. GAO suggested that if access is an issue, then DEA and registrants should communicate more regularly, including with clearer guidance, which could mitigate registrants’ fears of DEA action.
GAO Recommendations. GAO concludes by making three recommendations – each in an effort to strengthen DEA’s communications, guidance, and interaction with registrants:
- 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.
- 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.
DEA raised concerns about the second recommendation. DEA specifically stated that it cannot provide more specific information to distributors about suspicious order monitoring systems because those systems differ depending on the distributor. DEA noted it can educate through proactive interaction during inspections. GAO responded that inspections do not provide registrants with a “neutral education setting in which to obtain a better understanding of their CSA roles and responsibilities.” GAO also stated that DEA could provide better written guidance for distributors. Note that those that represent distributors likely believe that such guidance is only appropriate to the extent that it is promulgated through notice and comment rulemaking; otherwise it is not necessarily widely disseminated, well known, or generally available; nor does it provide enforceable obligations among registrants.
With respect to the third conclusion concerning soliciting input from pharmacists, DEA responded that it would update its Pharmacist Manual to address rescheduling of hydrocodone and new disposal rules, but it did not comment whether it would provide any additional guidance to pharmacies. GAO stated that any update should address a pharmacist’s corresponding responsibility under CSA. Industry would likely agree with GAO’s recommendation, especially given the recent (and significant) enforcement actions) DEA has taken against chain and independent pharmacies based on corresponding responsibility violations.