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    Subject Term: "Controlled substances"

    8 publications with a total of 27 open recommendations including 1 priority recommendation
    Director: Randall B. Williamson
    Phone: (202) 512-7114

    6 open recommendations
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that VA medical facilities have established an additional control procedure, such as an alternate controlled substance coordinator or additional inspectors, to help coordinators meet their responsibilities and prevent missed inspections.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that VA medical facilities have established a process where coordinators, in conjunction with appropriate stakeholders (e.g., pharmacy officials), periodically compare facility inspection procedures to VHA's policy requirements and modify facility inspection procedures as appropriate.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that medical facility directors have designed and implemented a process to address nonadherence with program requirements, including documenting the nonadherence and the corrective actions taken to remediate nonadherence or the actions that demonstrate why no remediation is necessary.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that networks review their facilities' quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help VHA achieve its objective of reducing the risk of diversion through effective implementation and oversight of the controlled substance inspection program, the Secretary of Veterans Affairs should direct the Under Secretary for Health to ensure that networks monitor their medical facilities' efforts to establish and implement a review process to periodically compare facility inspection procedures to VHA's policy requirements.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Seto Bagdoyan
    Phone: (202) 512-6722

    5 open recommendations
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal requesting authority to require SSNs for all individuals, regardless of whether they hold an individual or business registration.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us it is exploring the possibility and practicality of implementing policy or rule changes that would require Social Security Numbers (SSN) from all persons applying for a DEA Registration as a practitioner or mid-level practitioner. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop policies and procedures to validate SSNs and apply the policies and procedures to all new and existing SSNs in the CSA2; such an approach could involve collaborating with SSA to assess the feasibility of checking registrants' SSNs against the Enumeration Verification System.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that it had initiated discussions with the Social Security Administration (SSA) to determine the legality and feasibility of using SSA's Enumeration Verification System (EVS) to verify SSNs provided during the registration process. DEA stated that SSA has informed both GAO and DEA that its current legislative authorities do not authorize SSA to provide the information to DEA. As a a result, DEA stated that legislative action will be required to allow DEA additional access to EVS. As stated in our report, the use of EVS is one possible approach to validate SSNs. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal to request access to SSA's full death file.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that the Social Security Administration (SSA) determined that it cannot provide data from the full death file to DEA under existing law for use in administering the DEA Registration Process. DEA also said that if legislative changes allow DEA full access to SSA's full death file, DEA will work with SSA to ensure implementation of the new legislative authority. We continue to believe that DEA should develop a legislative proposal to request access to SSA's full death file and we will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should identify and implement a cost-effective approach to monitor state licensure and disciplinary actions taken against its registrants; such an approach could include using data sources that contain this information, such as the National Practitioner Data Bank or the Federation of State Medical Boards.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that currently, the Controlled Substance Act and its implementing regulations do not specifically give DEA authority to access state medical licensing boards' databases. DEA also said that it met with representatives of the Federation of State Medical Boards (FSMB) to develop a process that will allow DEA to accomplish the objectives GAO articulated in the draft report. Specifically, DEA said that it is exploring use of the FSMB service to verify the existence and status of state licenses to ensure all applicants for registration who are Doctors of Medicine and Doctors of Osteopathy, or Physician Assistants (in the states that provide this data to FSMB), meet the requirements to possess a DEA Registration. To implement the above described actions, DEA stated it will need to enter into an agreement with FSMB to provide this data in a format that allows real-time access to the data and accommodates the large numbers of applicants for DEA Registrations. DEA also said it obtained information from FSMB to begin the agreement process and is currently obtaining information on data elements that can be used to test user account codes to flag records in the FSMB. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should assess the cost and feasibility of developing procedures for monitoring registrants' criminal backgrounds, such as conducting matches against federal law-enforcement databases, and document decisions about the approach chosen.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us they are in the process of determining the feasibility of implementing actions that would permit DEA to comply with the recommendation utilizing the current legal framework and within reasonable cost parameters. DEA also said that the large volume of DEA registrations and the large number of applications received monthly present extensive technical and fiscal challenges with addressing this recommendation. We will continue to monitor DEA's progress in implementing this recommendation.
    Director: Cary B. Russell
    Phone: (202) 512-5431

    4 open recommendations
    Recommendation: To help ensure that DOD effectively evaluates the safety performance of carriers entrusted to transport security-sensitive materials in the Transportation Protective Services (TPS) program, the Secretary of Defense should direct the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, in collaboration with the U.S. Transportation Command to update TPS program guidance to clarify (1) how to address carriers with absent or dated Safety Ratings and poor Safety Measurement System scores, and (2) what specific actions should be taken when carriers do not meet program requirements.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To help ensure that DOD effectively evaluates the safety performance of carriers entrusted to transport security-sensitive materials in the Transportation Protective Services (TPS) program, the Secretary of Defense should direct the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, in collaboration with the U.S. Transportation Command to establish and document an approach for conducting reviews of available violation data, such as analyzing violations incurred while transporting TPS shipments.

    Agency: Department of Defense
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To improve DOD's ability to identify and effectively mitigate public safety risks of TPS carriers transporting security-sensitive materials, the Secretary of Defense should direct the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, in collaboration with the DOD Explosives Safety Board, the U.S. Transportation Command, the Surface Deployment and Distribution Command, and the Army Headquarters Safety Office, to develop department-wide guidance requiring the evaluation of the Defense Transportation Tracking System TPS carrier incident data to identify trends and patterns that could suggest systemic weaknesses such as mechanical breakdowns or unusual delays that represent a heightened potential public safety risk and take action to address any identified weaknesses.

    Agency: Department of Defense
    Status: Open

    Comments: According to TRANSCOM officials during our visit on April 2016--they are working on implementing these actions with a goal of completing them in Fall 2017.
    Recommendation: To improve DOD's ability to identify and effectively mitigate public safety risks of TPS carriers transporting security-sensitive materials, the Secretary of Defense should direct the Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, in collaboration with the DOD Explosives Safety Board, the U.S. Transportation Command, the Surface Deployment and Distribution Command, and the Army Headquarters Safety Office, to develop department-wide guidance requiring the identification and full investigation of TPS carrier incidents, including mishaps and near misses involving security-sensitive shipments, to determine potential root causes and identify corrective actions that could mitigate the recurrence of the mishap or the potential for more significant ones.

    Agency: Department of Defense
    Status: Open

    Comments: According to TRANSCOM officials during our visit on April 2016--they are working on implementing these actions with a goal of completing them in Fall 2017.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: As of March 2017, DEA officials reported that the agency was taking steps towards addressing this recommendation. In particular, DEA officials reported that they were in the process of developing a method to deliver information about registrant responsibilities through DEA's registration website, which registrants could access annually when they update their registration. DEA officials also reported that they would consider a method for registrants to subscribe to get email updates when new information is posted to Diversion Control Division website. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should 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.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In March 2017, DEA officials reported that the agency had worked with its Suspicious Orders Task Force to develop a draft Suspicious Orders regulation. They reported that the draft regulation was undergoing internal DEA review, but that it was uncertain when the draft regulation would be published in the Federal Register. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should 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.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In March 2017, DEA officials reported that while an update to the Pharmacist's Manual was still under way, they did not have an estimated completion date. We plan to continue to monitor the agency's efforts in this area, as well, and consequently this recommendation remains open.
    Director: Susan Fleming,
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: The Secretary of Transportation should direct the Administrator of NHTSA to identify actions--in addition to the agency's currently planned efforts--to support state efforts to increase public awareness of the dangers of drug-impaired driving. This effort should be undertaken in consultation with ONDCP, HHS, state highway-safety offices, and other interested parties as needed.

    Agency: Department of Transportation
    Status: Open

    Comments: NHTSA met with ONDCP, HHS, and GHSA in March 2016 and discussed what consumer research has been done and education materials have been used in raising awareness for the drug-impaired driving issue. NHTSA completed marijuana creative concept focus group market research in the Fall of 2016; however, the findings from this research were inconclusive. NHTSA plans to determine next steps and develop a new strategy in communicating on this challenging topic by Spring 2017. NHTSA anticipates conducting additional market research that will provide the direction for the development of creative materials by Fall 2017.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by the Food and Drug Administration Safety and Innovation Act, including a specific time frame in which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In June 2016, DEA stated that the agency had met with FDA to determine the specific procedures by which information regarding drug shortages will be exchanged pursuant to the Food and Drug Administration Safety and Innovation Act. DEA stated it will include these procedures in the work plan being created in response to the updated memorandum of understanding signed by FDA and DEA in March 2015. DEA officials also said that they plan to include in the work plan time frames for which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. As of July 2016, FDA officials said that it has completed its section of the work plan related to sharing information about drug shortages. Although GAO has been advised by DEA that the workplan has not been finalized, in August 2017, FDA stated that it and DEA are actively sharing information and have successfully completed numerous exchanges. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. GAO is continuing to monitor the status of this recommendation.
    Director: Fleming, Susan A
    Phone: (202) 512-2834

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to revise the SMS methodology to better account for limitations in drawing comparisons of safety performance information across carriers; in doing so, the Secretary of Transportation should direct the FMCSA Administrator to conduct a formal analysis that specifically identifies: (1) limitations in the data used to calculate SMS scores including variability in the carrier population and the quality and quantity of data available for carrier safety performance assessments, and (2) limitations in the resulting SMS scores including their precision, confidence, and reliability for the purposes for which they are used.

    Agency: Department of Transportation
    Status: Open
    Priority recommendation

    Comments: As of October 2016, FMCSA continues to maintain that they do not agree with our methodology or conclusions. While FMCSA's position about our specific recommendation is unchanged, FMCSA noted that Section 5221 of the FAST Act directed the National Academies of Science (NAS) to conduct a safety correlation study of the CSA program, and specifically FMCSA's Safety Measurement System's (SMS) methodology. FMCSA stated that if the outcome of the NAS study results in recommendations for SMS changes, they will address those recommendations accordingly. We continue to believe this recommendation has merit and could help the agency better target FMCSA's resources to the carriers that pose the highest risk of crashing, as we demonstrate in our report. For example, we reported that FMCSA requires a minimum level of information for a carrier to receive an SMS score; however, this requirement is not strong enough to produce sufficiently reliable scores. As a result, GAO found that FMCSA identified many carriers as high risk that were not later involved in a crash, potentially causing FMCSA to miss opportunities to intervene with carriers that were involved in crashes. FMCSA's methodology is limited because of insufficient information, which reduces the precision of SMS scores. GAO found that by scoring only carriers with more information, FMCSA could better identify high risk carriers likely to be involved in crashes. This illustrative approach involves trade-offs; it would assign SMS scores to fewer carriers, but these scores would generally be more reliable and thus more useful in targeting FMCSA's scarce resources.
    Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to ensure that any determination of a carrier's fitness to operate properly accounts for limitations we have identified regarding safety performance information.

    Agency: Department of Transportation
    Status: Open

    Comments: While FMCSA does not agree with our methodology or conclusions, we believe this recommendation has merit and could help the agency better target FMCSA's resources to the carriers that pose the highest risk of crashing, as we demonstrate in our report. For example, we reported that FMCSA requires a minimum level of information for a carrier to receive an SMS score; however, this requirement is not strong enough to produce sufficiently reliable scores. As a result, GAO found that FMCSA identified many carriers as high risk that were not later involved in a crash, potentially causing FMCSA to miss opportunities to intervene with carriers that were involved in crashes. FMCSA's methodology is limited because of insufficient information, which reduces the precision of SMS scores. GAO found that by scoring only carriers with more information, FMCSA could better identify high risk carriers likely to be involved in crashes. This illustrative approach involves trade-offs; it would assign SMS scores to fewer carriers, but these scores would generally be more reliable and thus more useful in targeting FMCSA's scarce resources.
    Director: Crosse, Marcia G
    Phone: 202-512-3407

    3 open recommendations
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should establish outcome metrics and identify resources for conducting outcome evaluations for the national education campaigns about prescription drug abuse and safe storage and disposal proposed in the Prescription Drug Abuse Prevention Plan.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should develop and implement a plan to evaluate outcomes from the proposed national education campaigns.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.
    Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should ensure that federal agencies undertaking similar educational efforts leverage available resources and use coordination mechanisms to share information on the development of their efforts.

    Agency: Office of National Drug Control Policy
    Status: Open

    Comments: In June, 2016, we requested an update from ONDCP on the status of its efforts to implement this recommendation. We have not received a response. We will update the status of this recommendation when we receive additional information.