Registering Emergency Medical Services Agencies under the Protecting Patient Access to Emergency Medications Act of 2017
2020-10-08 2020-10-08 2020-11-25 2020-11-09 2020-12-03 2020-12-03 2020-12-07 2020-10-13 2020-10-16 2020-12-03
DEA-2020-0029-0007 DEA-2020-0029-0006 DEA-2020-0029-0027 DEA-2020-0029-0026 DEA-2020-0029-0042 DEA-2020-0029-0036 DEA-2020-0029-0056 DEA-2020-0029-0014 DEA-2020-0029-0018 DEA-2020-0029-0038
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https://api.regulations.gov/v4/comments/DEA-2020-0029-0007 https://api.regulations.gov/v4/comments/DEA-2020-0029-0006 https://api.regulations.gov/v4/comments/DEA-2020-0029-0027 https://api.regulations.gov/v4/comments/DEA-2020-0029-0026 https://api.regulations.gov/v4/comments/DEA-2020-0029-0042 https://api.regulations.gov/v4/comments/DEA-2020-0029-0036 https://api.regulations.gov/v4/comments/DEA-2020-0029-0056 https://api.regulations.gov/v4/comments/DEA-2020-0029-0014 https://api.regulations.gov/v4/comments/DEA-2020-0029-0018 https://api.regulations.gov/v4/comments/DEA-2020-0029-0038
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1304.27 (a) Each emergency medical services agency registered pursuant to 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record:The use of the word dose should be heavily re-considered. EMS units often will administer multiple doses of a drug to a patient. For example, 25mcg of Fentanyl to a geriatric to ensure that they tolerate it well, before administering a second 25mcg dose.The use of the word dose could make each emergency run require multiple logs for controlled substance administration, adding significantly to the paperwork burden, while creating unseen incentives that impact how often paramedics administer medications that are clinically indicated. For example, as mentioned above, perhaps the paramedic will be incentivized to administer the full 100mcg vial of Fentanyl to the patient because they want to see the patients pain controlled, but do not want to make 4 duplicative records for each 25mcg administration. Now, the patient receives the 100mcg and the patient suffers a side effect of vomiting and respiratory depression. The paperwork burden of healthcare is already high enough. The use of the word dose should be removed, and record requirements should be based on the type of controlled substance per ambulance run. Redundancy as required by the word dose will negatively impact patient care without any significant impact to reducing diversion. I.E. if the paramedic has a standing order to administer up to 200mcg of Fentanyl for pain in doses of 25mcg-100mcg, and they administer 3 doses of 50mcg and wasted 50mcg. They should be required to create ONE record that indicates that they administered 150mcg of Fentanyl and wasted 50mcg. Not three to four duplicative records.1304.27 (a) (2) Finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);This provision should receive extra consideration. Is the intent to create duplicative records when a patient requires more than one unit dose (container/vial) of a medication? At times medications come in a variety of concentrations due to shortages. At times, patients require more than one unit dose (or container/vial) of the medication during the course of EMS treatment. Does tracking the finished form of each administration lend more positive impact on preventing diversion than it costs in paperwork burden? Im inclined to say that it does not.Again, as noted above in comments on dose this provision should be removed. 1304.27 (a) (7) Initials of the medical director or authorizing medical professional issuing the standing or verbal order;This provision should be altered as it will create a significant burden on both the EMS agency and medical professional. In relation to verbal orders under some medical control systems are from a physician that is located at a central location, or other location that the EMS unit will not be physically present at. To physically or electronically track down the medical professional giving the order, is impractical and problematic. In relation to standing orders, the medical professional has already signed the order. While a review of the controlled substance administration may be appropriate, a requirement that the medical director initial each administration record is problematic and redundant, as again, this medical director is infrequently physically present in the course of the duties of the paramedic who followed the standing order and administered the controlled substance. The purpose of standing orders is to allow the paramedic to follow the orders without the physical or verbal presence of the medical professional. Tracking an individual down after delivering a patient to the hospital or other location (as is starting to be allowed by billing practices and Medicare) negates the benefit of standing orders to patients and EMS systems who will now have to exert significant effort to obtain two to three letters on paper.Implementing this rule as written will cause undue burden on the EMS system and medical professionals overseeing them, and will be especially problematic in super rural, and highly busy urban systems; Possibly causing racial disparities in who actually receives these medications in times of need.I recommend that you replace this provision with a requirement that the paramedic document the name of the medical professional providing the standing or verbal order, with the last name being sufficient. EMS personnel should be required to report and be monitored on their use (patient administration) of scheduled medications to a registry board (much like Prescription Drug Monitoring Program) in hopes to minimize over use (administration) of medications. At this education level (medic) the overall whole person is not considered in patient care. Sadly, in my experience (from a medical perspective), medics tend to medicate and over medicate just for a smooth ride so to say.  How do these regulations impact those medical directors that are overseeing multiple agencies within their EMS System, such as in Illinois?  Illinois utilizes EMS Systems in which an agency must be a part of, according to the Illinois EMS Act.  The rules only state agency and does not seem to fit into the way EMS is ran in Illinois where there are multiple agencies in one system.     Regarding the security of controlled substances, the first option in proposed 1301.80(b)(1) would allow for an EMS agency to store controlled substances in a securely locked, substantially constructed cabinet or safe that cannot be readily removed. This storage component must be located at a secured location, as stated in proposed 1301.80(i).  The second option in proposed 1301.80(b)(2) would allow an EMS agency to store controlled substances in an automated dispensing system (ADS) machine, under specific conditions.Under, WV state law (Policy Number: 4.12-082013), ALS providers may have medication stored in the ambulance jump bag. However the jump bag must be secured using a device such as a tamper detectable plastic lock. The bag must be stored in a secured locked location on the ambulance or in the Agency Station. ALS providers or the Registrants designated personnel (Power of Attorney as described above) must be in control of the bag at all times when not locked in a secure location.It appears that the proposed rule would eliminate the possibility of storing controlled substances in a jump bag in order for the EMS personnel to have quick access in an emergency situation. Section (G)(1) related to standing orders: In Pennsylvania standing orders (statewide protocols) are issues by the Pennsylvania Department of Health. EMS Agency Medical Directors are not permitted to issue their own standing orders (protocols), nor are they permitted to alter a statewide protocol, except as may be permitted within a specific protocol.Section (G)(1), as currently drafted, creates a conflict with Pennsylvania EMS statute and regulation. The Pennsylvania Emergency Health Services Council, who is the Pennsylvania Department of Healths advisory board on EMS related matters, recommends consideration of the following amended language:Section (G)(1)Standing orders that are developed by a state authority may be issued and adopted by the medical director of an EMS Agency [OR BE AUTOMATICALLY ISSUED AND ADOPTED WHEN REQUIRED BY STATE STATUE OR REGULATION.]  Under the Act and proposed regulations, only the medical director of an EMS agency [OR STATE AUTHORITY] is given authority to issue and adopt a standing order In our opinion, the recommended language change would not diminish the effectiveness of the proposed regulations with regard to authority, accountability or security. 1304.27(a) states that, any EMS personnel who disposes of or administers controlled substances to a patient in the course of providing emergency medical care must record the name of the controlled substance(s) and detailed information about the circumstances surrounding the administration of the controlled substance(s) (e.g., name of the substance, date dispensed, identification of the patient)... While sensible in theory, in reality EMS work is often chaotic with back-to-back calls and many distractions between patients, as in the case of a car wreck with multiple victims, or a mass casualty event such as a mass shooting or other accident. In such instances, it may be nearly impossible for an individual to collect and retain such detailed information as the names of those who are administered critical care involving controlled substances, beyond the timeframe of the event, to be recorded properly.  What protections will be put in place for EMS workers who are unable to provide this information due to extenuating circumstances, or who make mistakes in their record keeping after a mass casualty type event?  1) Section 1300.06(b)(14)  Definition of StationhouseThe proposed definition of stationhouse will work well for some EMS systems and poorly for others. Particularly, many EMS systems will likely need to designate locations where EMS vehicles, equipment or personnel are housed understanding that such locations may or may not actually house vehicles inside. This is particularly true in urban systems that use central supply facilities, air ambulance bases and other arrangements where vehicles are not permanently housed or stored indoors. As such we recommend the following change to the definition:Stationhouse means an enclosed structure that houses one or more emergency medical services agency vehicles, equipment or personnel within a State in which that emergency medical services agency is registered, and that is actively and primarily being used for emergency response by that emergency medical services agency. (2) Section 1301.20 - Ability of an emergency medical services agency to register  We appreciate the statutory and regulatory changes that clarify that an EMS organization may register directly with the DEA. We believe this approach removes historic ambiguity where the agency registration may have been combined or confused with the registration of an individual physician or physicians. As such, we strongly support the ability of an EMS agency to be held accountable for compliance with these regulations separate from physicians who legally authorize the administration of controlled substances by standing or verbal order. We would further discourage the DEA from making any changes that obscure or diminish the ability of the EMS agency to develop and implement policies and procedures to comply with these regulations including but not limited to review or approval by third parties.  (3) Section 1304.27 - Additional recordkeeping requirements applicable to emergency medical services agencies.  The proposed rule would require the initials of the medical director or authorizing medical professional issuing the standing or verbal order in each record for each dose of controlled substances administered or disposed of in the course of providing emergency medical services.  As a practical matter, the standard electronic patient charts utilized for emergency medical services do not provide a means by which the medical director can initial the chart.  However, the National Emergency Medical Information System (NEMSIS) already includes as a data element in the record to indicate the standing order being utilized. For verbal orders, the name of the physician or authorizing medical professional is entered as well.  Accordingly, we urge the Attorney General to remove the requirement for the medical director or authorizing medical professional to provide initials in the record.  Instead, the final rule should simply require that the record specifically reference the standing order utilized to administered the controlled substance and the name of the medical director that issued the standing order.  For verbal orders, the record should specifically reference the name of medical director or authorizing medical professional that issued that particular verbal order for that particular patient. We further believe cross referencing a patient chart to the controlled substance log will add an additional level of accountability  (4) Allowance for security and chain of custody outside of a vehicle or building. The final rule should provide a section to recognize that day-to-day operational needs may require controlled substances be removed from a vehicle or station and kept with an accountable individual for some or all of a shift. This could include situations where providers are not assigned to an automobile and only have portable equipment, when temperatures prohibit safe storage in a vehicle, or when central supply stations issue a limited amount of controlled substances in a kit for use during their shift. We urge the Attorney General to recognize this practice exists and that the rule should require adequate security, chain of custody and inventory controls, much like those already in the proposed rule, for this practice when used.   1304.27 Additional record keeping requirements applicable to emergency medical services agencies.(a) Each emergency medical services agency registered pursuant to 1301.20 of this chapter (including a hospital-based emergency medical services agency using a hospital registration under 1301.20(a)(2) of this chapter) must maintain records for each dose of controlled substances administered or disposed of in the course of providing emergency medical services. The following information shall be included in each record: (7) Initials of the medical director or authorizing medical professional issuing the standing or verbal order;I respectfully request that item 7 is looked at for reconsideration. Many EMS agencies operate under very specific standing orders. A system that works very well for many obvious reasons. I do not believe that it is practical to obtain the initials of the medical director or authorizing medical professional for each dose.Thank you for your time and consideration.  1304.03 Must have record keeping of the EMS personnel due to state laws having different requirements. (a) EMS personnel may not always return to the station house due to the fact that if an emergency response that is being acknowledged was done well they do not have to time to go back to restock their controlled substances. The Act allows EMS to receive controlled substance from a non hospital-base agency. This is important due to the fact that they are constantly receiving phone calls about an emergency that needs to be taken care of. 1301.80 (b) DEA wants to add more storage for EMS agencies so that they have more options of their controlled substances. EMS agencies require more options due to the fact that they never know what type of emergency theyre are responding to. They would be securely locked and safe so that no just anybody can break into the substances. The areas will be locations that are designated or registered. I, respectfully, ask for 1304.03 to be reconsidered since it makes sense why the EMS need their remote locations. They are the ones who try to keep people alive before getting to the hospital.  As someone who worked as an EMT for quite some time, I support the 2017 act which allows EMTs and paramedics the ability to administer these controlled substances for primary two reasons. The first is that EMS personnel are expected to quickly and effectively respond to crisis  and for tens of millions of Americans annually, EMS personnel are the first point of healthcare treatment. As such, considering the need for EMS agencies to adequately treat medical conditions of huge variance, I am in support of these same agencies possessing the grounds to use medical tools and substances which help them treat the large spectrum of medical conditions encountered daily. Because of this, I find it especially important for the Attorney General to implement the Act to save for any uncertainty for emergency medical services agencies.