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Safety Recommendation Details

Safety Recommendation R-00-002
Details
Synopsis: The National Transportation Safety Board has investigated many incidents in all passenger transportation modes in which the use of a licit medication by a vehicle operator has been causal or contributory. As a result, the safety board has previously recommended that various agencies take certain actions to address issues pertaining to the use of medications.
Recommendation: TO THE FEDERAL RAILROAD ADMINISTRATION: Develop, then periodically publish, an easy-to-understand source of information for train operating crewmembers on the hazards of using specific medications when performing their duties.
Original recommendation transmittal letter: PDF
Overall Status: Open - Unacceptable Response
Mode: Railroad
Location: Burnt Cabins, PA, United States
Is Reiterated: No
Is Hazmat: No
Is NPRM: No
Accident #: HWY98MH033
Accident Reports: Greyhound Motorcoach Run-Off-The-Road Accident
Report #: None
Accident Date: 6/20/1998
Issue Date: 1/13/2000
Date Closed:
Addressee(s) and Addressee Status: FRA (Open - Unacceptable Response)
Keyword(s):

Safety Recommendation History
From: FRA
To: NTSB
Date: 2/25/2019
Response: -From Ronald L. Batory, Administrator: As promised in our 2015 letter to the NTSB, FRA has developed an "Rx-OTC Policy Toolkit" that includes general information about the importance of consulting a physician before using a new prescription (Rx) or over-the-counter (OTC) medication. This Toolkit, available on FRA's website, also discusses FRA's requirements on the use of prescription and OTC drugs for regulated employees(§ 219.103 of FRA's drug and alcohol regulation in 49 CFR part 219), and the risks of using medications with potential adverse effects. 1 FRA is also developing an online interactive training and testing module on medication use. FRA will update both the Toolkit and the training module periodically. In addition, on September 13, 2018, FRA sent a letter to railroads addressing legitimate medication use by their employees (enclosed). Each railroad will be able to use FRA's Rx-OTC Toolkit to develop internal policies such as requiring employee notification of the use of sedating medications, establishing railroad medical review of medication use by employees, and restricting medication use appropriately. While establishing these policies can be costly and time-consuming, FRA encourages railroads to do so to facilitate employee compliance, based on the railroad's own safety risks compared to its cost and privacy analysis. Because FRA has developed a model training program, encouraged railroads to use it, and has continued to update the program, FRA respectfully requests that the NTSB classify Safety Recommendations R-00-02 and R-00-03 as "Closed-Acceptable Action."

From: NTSB
To: FRA
Date: 5/15/2015
Response: We are disappointed that these recommendations are nearly 15 years old without your having implemented them; however, we understand that you intend to develop a training module that will include general information about the importance of consulting a physician regarding the use of any prescription or over-the counter medication, FRA requirements regarding prescription and over-the-counter (OTC) drug use, and a discussion of potentially risky use of medications. We further note that, when the training module is completed, you will post it on your website and widely publicize its availability for industry use. We understand that your interactive website (http://railroadersleep.org/), available to users beginning in June 2012, provides information about managing sleep, fatigue, and sleep disorders. Unfortunately, we found that the site is somewhat difficult to find using existing search strategies. Although NTSB staff was able to locate it using the search engines Google or Yahoo when querying “railroad” and “sleep,” the site could not be located on the first three pages of search results on either engine when staff searched on various combinations of “engineer,” “railroad,” “sleep apnea,” and “fatigue.” In addition, staff could not find a link to the site on the FRA website, either under the “Safety” tab or in the first 30 search results using the key words “sleep” or “fatigue.” Therefore, we believe that this resource is likely not being used effectively by train crewmembers, and we are concerned that any new electronic resource developed in response to these medication recommendations may be similarly hard to find. Although we believe your plan to ask the DOT’s Office of Drug and Alcohol Policy and Compliance (ODAPC) to publicize the module and to post it on the ODAPC website will be helpful to many, we are concerned that train crewmembers are unlikely to visit that website. Therefore, in consideration of the long delay in addressing this recommendation and the lack of effective action, beyond planning, that has occurred to date, Safety Recommendations R-00-2 and -3 remain classified OPEN—UNACCEPTABLE RESPONSE pending substantive, effective progress to address them. We encourage you to expedite your planned actions and remind you that, to satisfy Safety Recommendation R 00-2, you will not only need to develop the training module, but will also need to actively encourage its use and to update it periodically.

From: FRA
To: NTSB
Date: 1/27/2015
Response: -From Sarah Feinberg, Acting Administrator: This letter is to update you on the status of the National Transportation Safety Board's (NTSB) Safety Recommendations R-00-01 through R-00-04, R-01-17, and R-08-07, issued to the Federal Railroad Administration (FRA). Safety Recommendation R-00-01 asks FRA to establish procedures and criteria for train operating crewmembers who take medications on a list of drugs approved by the U.S. Department of Transportation (DOT). Safety Recommendations R-00-02 through R-00-03 ask FRA to address the hazards of train operating crewmembers using specific medications while performing their duties. Safety Recommendation R-00-04 asks FRA, in coordination with DOT, the Federal Motor Carrier Safety Administration, the Federal Transit Administration, and the U.S. Coast Guard, to conduct post-mortem toxicological testing on a sample number of accident fatalities to determine if the use of prescription and over-the-counter drugs played a role in these fatal accidents. Safety Recommendation R-01-17 asks FRA to narrow its current highway-rail grade crossing exemption to allow the post-accident toxicological testing of any employee who may have contributed to the occurrence or severity of an accident. Finally, Safety Recommendation R-08-07 asks FRA to expand the scope of its drug and alcohol testing program to cover all employees and agents performing the functions listed in Title 49 Code of Federal Regulations Section 209.303. In Enclosure 1, FRA explains the actions that it has taken in response to Safety Recommendations R-00-01 through R-00-04, R-01-17, and R-08-07. FRA respectfully requests that the NTSB classify Safety Recommendation R-00-01 as "Closed-Unacceptable," Safety Recommendations R-00-02 through R-00-04 and R-08-07 as "Open-Acceptable Response," and Recommendation R-01-17 as "Closed-Acceptable Action." We look forward to continuing to work with you on important safety issues. Specifically, FRA intends to respond to R-00-02 and R-00-03 by developing an optional training module on the hazards of using specific medications. This module will be made available for free on FRA's Web site to enable the rail industry to use as is or to provide a model for its own training on this subject. The module, which will also be available for download by individual railroad employees, will include: • general information on why it is important for a safety-sensitive employee to consult with a physician, and comply with the physician's directions and restrictions, when taking a prescription or OTC drug for the first time; • Title 49 Code of Federal Regulations (CFR) Section 219.1 03's requirements for the use of prescription and OTC drugs, and • and a discussion of potentially risky conduct; such as: o the mixing of medications, the use of mail order or internet pharmacies, o the use of a prescription for a purpose other than it was prescribed for, and o the use of a drug prescribed for someone else. When completed, FRA will publicize the availability of the training module to FRA's railroad contacts, regional offices, inspectors, and other interested parties. FRA will also ask DOT's Office of Drug and Alcohol Policy and Compliance (ODAPC) to announce the new module to its distribution network and to make the module available on the ODAPC Web site. In addition, FRA will conduct outreach at its own training sessions, at industry conferences such as the Railroad Roundtable, and at labor and trade association meetings.

From: NTSB
To: FRA
Date: 1/15/2014
Response: Our last letter from the FRA regarding Safety Recommendations R-00-1 through 4 was dated July 24, 2009. Based on information contained in that letter, these recommendations were classified “Open—Acceptable Response” on June 8, 2010, pending the publication of final rules that would satisfy them. We have no evidence that the FRA has made progress on these issues since 2009. Accordingly, pending our receipt of an update from the FRA regarding its actions to address Safety Recommendations R-00-1 through -4, these recommendations are classified OPEN—UNACCEPTABLE RESPONSE.

From: NTSB
To: FRA
Date: 12/1/2011
Response: CC# 201100449 was closed administratively; no response was written or mailed.

From: FRA
To: NTSB
Date: 4/12/2011
Response: -From Ray LaHood, Secretary of the United States Department of Transportation: NTSB Classification and Actions Taken by FRA: Open – Acceptable Response. In 2002, NTSB officials met with members of FRA’s RSAC to discuss concerns with NTSB Rec. Nos. R¬00-01 through R-00-04 and clarify their intent. In 2007, RSAC’s Medical Standards Working Group was established to address these recommendations and other fitness-for-duty (FFD) concerns. Although the working group was able to achieve consensus on some of the text for a Medical Standards NPRM during 2010, the group remained unable to agree on such issues as the scope of the rule, whether it will set minimum or uniform standards, and what its dispute resolution procedures will be. At its August 31-September 1, 2010 meeting, the group decided to transfer the issue of medications reporting and education to the forthcoming alcohol and drug (49 CFR Part 219) rulemaking. The group’s Doctors Task Force (DTF) will continue its work on drafting standards for hearing, vision, stroke, cardiac conditions, insulin-dependent diabetes, syncope, and obstructive sleep apnea. FRA is planning to issue a Medical Standards NPRM in 2011. Actions Needed to Be Taken by FRA: Complete and publish guidance document. Issue regulations.

From: NTSB
To: FRA
Date: 6/8/2010
Response: As discussed above, the Medical Standards Working Group is developing guidance material for employees with regard to prescription drugs and OTC medications and continues to develop recommendations for inclusion in the NPRM due out at the end of 2010. As the FRAYs Medical Director indicated in his conversation with NTSB staff, he plans to share this guidance material with the Working Group at its next meeting. Accordingly, pending completion of a final rule regarding guidance material for crewmembers on the hazards of the use of specific medications when performing their duties, Safety Recommendation R-00-2 is classified OPEN -- ACCEPTABLE RESPONSE.

From: FRA
To: NTSB
Date: 7/24/2009
Response: Letter Mail Controlled 7/28/2009 4:24:35 PM MC# 2090479 - From Joseph C. Szabo, Administrator: In 2002, NTSB officials met with members of FRA's RSAC to discuss concerns with NTSB Recommendations R-00- 1 through R-00-4. At that meeting, NTSB clarified the intent of Recommendations R-00-1 through R-00-4 OPEN -- ACCEPTABLE RESPONSE. In 2007, RSAC's Medical Standards Working Group was established to address these recommendations and other fitness-for-duty concerns. The Working Group continues to develop recommendations for issuing an NPRM in 2009. An essential part of this activity is the development of guidance material for employees with respect to over-the-counter and prescription medications. FRA's Medical Director has prepared detailed guidance material that will be shared with the Working Group at its next meeting. The FRA respectfully requests that NTSB continue to c1assiQ this recommendation as "Open-Acceptable Response," until such time as FRA has published its NPRM.

From: NTSB
To: FRA
Date: 5/1/2002
Response: A letter was sent to the modal administrators with the following: Since the November 2001 meeting, the FRA invited Safety Board staff to present the Board’s concerns regarding the potential hazards of medication use by transportation operators to the Railroad Safety Advisory Committee (RSAC). That presentation allowed for the free exchange of ideas and concerns, and was, in our opinion, highly productive. We recognize that the RSAC process is a potentially long one, but believe that the FRA has initiated action consistent with the intent of the Board’s recommendations. We are therefore classifying those recommendations directed at the FRA (Safety Recommendations R-00-1 through -4) as OPEN -- ACCEPTABLE RESPONSE. The RSAC meeting also allowed us to address two apparent potential misunderstandings about the recommendations as they now stand. One, the Board is not recommending that the DOT or any modal administration evaluate each and every drug for its potential to impair vehicle operators. We understand that this is neither feasible nor rightfully within the domain of the DOT. We are recommending that the DOT develop a relatively short list of medications or classes of medications that have been evaluated and found safe for use by vehicle operators, perhaps analogous to similar lists currently provided by the military services for their pilots. Two, the Board is not recommending a new, potentially intrusive, certainly expensive program of testing all vehicle operators for the use of licit medications. The intent of the recommendation was to increase the comprehensive testing rate of fatally injured operators so that, as is done in the FAA, a database can be built to allow determination of the actual extent to which use of potentially impairing medications is a problem in each transportation mode. We believe that it may be productive to invite staff from the DOT and/or each of the modal agencies to discuss with our staff their concerns, priorities, and resource limitations before the Safety Board classifies the open recommendations to the DOT and other modal agencies. Based on our experience with the public meeting and the RSAC, it seems possible that such a meeting could result in some potentially acceptable alternate actions with regard to the current recommendations. We also recognize that each individual modal administration has a unique perspective and approach to the issue of medication use. A meeting between staff could allow a complete discussion of the various distinctive concerns in each transportation mode. If desired, the FDA staff who participated in the public meeting could also be invited for their technical expertise. We are available to meet individually with the modal agencies or as a group.

From: FRA
To: NTSB
Date: 8/17/2000
Response: Letter Mail Controlled 08/22/2000 9:26:00 AM MC# 2001092: - From Jolene M. Molitoris, Administrator: The implementation of a list that expressly prohibits use of medications is fraught with the same problems identified with establishment of a list approving certain medications. Here again, FRA does not believe this type of list would be effective in diminishing inappropriate use of prescription or OTC medications. As noted previously, such a list would be difficult to keep updated and would give false assurances to individuals performing safety-sensitive functions that if a substance was not on the list, it could safely be taken while performing a safety sensitive job. FRA will continue to emphasize the importance of having employees consult with medical practitioners concerning the effect of medication on safe job performance and will direct the industry to continue to stress education and training of supervisors and operators. FRA is making this issue a priority in all compliance and enforcement reviews, accident investigations, and complaint investigations. Additionally, FRA has recently published a set of guidance documents, which clearly provide guidance to FRA inspectors, railroad employers, and our labor Partners on this critical subject. FRA will monitor the effect of this effort and adjust as we see the need.