Sailing the Unknown Waters. EMS Medicine, DEA Regulations, and Various Ruminations 1/25/2013. Raymond L. Fowler, MD, FACEP

Transcription

1 Sailing the Unknown Waters EMS Medicine, DEA Regulations, and Various Ruminations Raymond L. Fowler, MD, FACEP Professor of Emergency Medicine Chief of EMS Operations Co-Chief in the Section on EMS, Disaster Medicine, and Homeland Security Section on Resuscitation Research UT Southwestern Medical Center Attending EM Faculty, Parkland Hospital 1

2 seizing like a hooked tuna Beginnings... 2

3 EMS Medicine The EMS Physician The National Association of EMS Physicians 3

4 Cardiopulmonary Resuscitation First described in 1960 by Safar, Jude, Kouwenhoven, and Knickerbocker San Diego,

5 September 16, 1960 Thou Join faithful now servants, the September 16, 2010 you House have of labored Medicine well September 23, 2010 The We re Rate growing of Change and changing is logarithmically Accelerating Medics Activating Cath Labs Broad Citizen CPR Training Symptom Onset to Arterial Reperfusion Statewide Resuscitation Centers The Resuscitation Outcomes Consortium NEMSIS Disaster Medicine Training MedStar Mobile Health Evolution Health Health Information Exchanges and the need for epcr Exchanges Technical Interoperability 5

6 Key studies 6

7 Survival Survival drops quickly with compression rates over 120 Compression beats/minute Rate 7

8 And Many Other Points Rate Depth Pauses Compression Fraction Deemphasize Ventilation Airway Management With privilege comes responsibility We Are a Specialty And now, we have to act like one 8

9 We have both an Ethical and a Moral Imperative Increase the human condition through commitment and devotion to duty The Ethical and Moral Violation Harming another human through dereliction of duty Dereliction of Duty Knowingly failing to apply all due diligence to someone in need 9

10 The Great Risks of EMS Airway Management Driving Practices Non-transport of clients How many medics were trained, in their I Worry initial About training program, This about how to safely non-transport a patient? Psalm 39:5: Verily, every man at his best state is altogether vanity. 10

11 Paint Gun Non-Transport of EMS Patients: Identification of Individual Paramedic Crew Behaviors Through System-wide Automated Audit Mechanisms Raymond L. Fowler, MD; Paul E. Pepe, MD, MPH; David M. Melville, BS; and Alexander L. Eastman, MD The Section on Emergency Medical Services, Department of Surgery University of Texas Southwestern Medical Center Background Results Conclusions Many EMS systems use non-transport policies to optimize resource utilization. While well-intended, such policies may increase the risk of mistriage and potential for bad outcomes. Therefore, in any system allowing non-transports, effective monitoring methods are strongly recommended. The purpose of this study was to demonstrate the utility of a system-wide audit of automated EMS records to identify varying rates of non-transport among individual paramedic crews, thus allowing identification of potential areas for focused investigation and intervention. Methods A retrospective analysis of 906,011 EMS incidents from 1998 to 2003 in a large, urban EMS system was performed. Data from computerized EMS patient records were reviewed and entered into a proprietary Microsoft FoxPro (Microsoft Corporation; Redmond, WA) database. Generated reports were then exported into Microsoft Excel for compilation and analysis. These data were analyzed with specific regard to variation in the rate of non-transport across individual crews, shifts and stations. During the 6-year study, no patient was transported to a hospital in 541,920 incidents (59.8%). Great variability was found in both the rate and reason for non-transport. The highest overall rate of non-transport by an individual crew, Shift 1, was found to be 73.8% and this individual crew maintained the highest nontransport rate in the system for five of the six study years. A second crew at the same station, Shift 2, had an overall non-transport rate of only 58.1% (OR: 1.9 [1.8,2.1] P=< ). The EMS-initiated (versus patient-initiated) nontransport rate for Shift 1 was 21.4%, as compared to Shift 2, whose EMSinitiated non-transport rate was 14.9% (OR: 1.9 [1.7,2.1] P=< ). System-wide, the overall EMSinitiated non-transport rate was 8.4% (range: 2.8%-21.4%). In a large urban EMS system, considerable variability exists between individual crews regarding both the rate of nontransports and the reasons for non-transport. While multiple geographical and sociological variables may explain this variation, across the system, this analysis still provides strong data to justify targets for review (e.g. large differences in transport rates at the same station on different shifts). Further study should determine whether this focus allows medical directors to more efficiently direct corrective interventions and provide remedial training where indicated. 11

12 We pulled 906,011 records over six years looking at non-transport trends We found that one shift in one station was 100% more likely to no-load patients than the shift at that station with the lowest non-transport rate P value = < You MUST NEVER try to talk a patient out of going to a hospital to serve your needs 12

13 That is a sin It is wrong It may hurt somebody So, The we Problem get away is with that it most for awhile, people maybe are not a long injured while, until (at least something badly) by terrible a non-transport happens It isn t what it ISN T, but what it MIGHT BE that will get you in trouble and possibly harm your patient! 13

14 Remember the Moral Imperative To Better the Human Condition We Have to Take this Oath Never EVER render a medical opinion which you are not qualified to render This is rampant behavior in our industry and, with the coming of the Community Paramedic, we must use all due caution to express diagnoses and judgments carefully 14

15 1/25/2013 1/25/

16 1/25/2013 1/25/

17 The Drug Enforcement Administration and Emergency Medical Services 1/25/2013 A recent case in Texas Volunteer EMS Medical Director Tiny Volunteer Service Narc Control Policy in Place Conducted Annual Audits 20 Year Relationship Trusted PM Director A recent case in Texas Med Director rolled out fentanyl Conducted audit in November PM Dir began stealing fentanyl for his wife s headaches Diverted ~240 ampules over a year s time 17

18 A recent case in Texas When questioned by partner Said have Med Dir s permission Kept separate med records Mother complained to DSHS DSHS contacted Med Dir who promptly conducted audit A recent case in Texas Med Dir discovered the diversion Reported PM to state Reported matter to DEA Assumed that all was well A recent case in Texas Hearing before ALJ PM decertified No recommendations Thought all was okay 18

19 Then it got ugly A recent case in Texas Without an order from ALJ, DSHS reported MD to BOME BOME began license revocation DEA initiated investigation A recent case in Texas DEA found Med Dir liable DEA found PM Dir liable DEA found PM partner liable 19

20 A recent case in Texas DEA fined the Medical Director $2,800,000 in total due to the fentanyl diversion Same fines against the PM s A recent case in Texas Attorney R. Jack Ayres was engaged to defend the case Successfully argued before the Texas Medical Board DEA settled for $16,000 Item Analysis The DEA 222 Form 20

21 Copy 3 So what if I don t fill out copy III? $10,000 per dose $16,000 fine 21

22 Copy 1 Copy 3 The DEA 222 Form Copy 1 Copy 3 The DEA 222 Form 22

23 so who are these guys? The Drug Enforcement Administration was established on July 1, 1973, by Reorganization Plan No. 2 of 1973, signed by President Richard Nixon It proposed the creation of a single federal agency to enforce the federal drug laws as well as consolidate and coordinate the government s drug control activities. The DEA is headed by an Administrator of Drug Enforcement appointed by the President of the United States and confirmed by the U.S. Senate. The Administrator reports to the Attorney General through the Deputy Attorney General 23

24 The 2010 DEA budget was directed toward three of five major goals of U.S. drug eradication: Demand reduction ($3.3 million) via anti-legalization education, training for law enforcement personnel, youth programs, support for community-based coalitions, and sports drug awareness programs. Reduction of drug-related crime and violence ($181.8 million) funding state and local teams and mobile enforcement teams. Breaking foreign and domestic sources of supply ($ billion) via domestic cannabis eradication/suppression; domestic enforcement; research, engineering, and technical operations 24

25 and the Foreign Cooperative Investigations Program; intelligence operations (financial intelligence, operational intelligence, strategic intelligence, and the El Paso Intelligence Center); AND DRUG AND CHEMICAL DIVERSION CONTROL. 25

26 Separate Registrations? Question: Are separate registrations required for separate locations? Answer: A separate registration is required for each principal place of business or professional practice where controlled substances are stored, administered, or dispensed by a person. If a practitioner will only be prescribing from another location(s) situated within the same state, then an additional registration is not necessary. 26

27 The overall goal of the Controlled Substances Act (CSA) and of DEA's regulations in Title 21, Code of Federal Regulations (CFR), Parts is to provide A CLOSED DISTRIBUTION SYSTEM so that a controlled substance is at all times under the legal control of a person registered, or specifically exempted from registration, by the Drug Enforcement Administration until it reaches the ultimate user or is destroyed. Disposal of Controlled Substances: 1. Return to the manufacturer 2. Follow procedures under21 CFR Reverse Distribute 27

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30 Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag. 30

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32 The Mid-Level Practitioner 32

33 ov/drugreg/practioners/mlp_by_ state.pdf From the case I discussed, it is clear that the DEA s position is that the Medical Director is absolutely liable for the narcotics authorized for purchase under that physician license When was the last time that you REALLY reviewed: Your narcotic control policy The receipt into inventory Runsheet documentation Periodic inventory Investigations 33

34 YOU MUST HAVE A WELL CRAFTED NARCOTICS CONTROL POLICY I AM SHOUTING!!! The policy must provide accountability for every single molecule EVERY AMPULE EVERY TIME WITHOUT EXCEPTION 34

35 It s apparent from the recent DEA action that anything other than a very precise narcotics control policy is unacceptable As It SHOULD be Four essentials of a solid narcotics control policy Establish Initial Inventory Reordering based ONLY upon documented usage Periodic Inventories Standard investigation 35

36 Reordering and Resupply Must be based strictly upon documented usage Must include written documentation of the usage Must include wastage DO NOT REORDER/RESUPPLY WITHOUT CONFIRMED USAGE Periodic Inventories Daily in the central storage Daily on the ambulances Daily on any intermediate locations Spot unscheduled inventories Signatures coming on and off Test your system Come in on a weekend Check drug box during rideout Make sure all locks are in place Have a unit come in for a random spot check BE CREATIVE! 36

37 Investigation Policy Every missing drug, every time Includes ALL involved staff Initiated AT THE TIME of discovery of inventory mis-match Get the shift OUT OF BED Drug screens where indicated Document-Document-Document New Ideas for the Electronic Age Electronic PCR inventory control program epcr Notification system STAT tracking of documentation errors Documentation Errors Unacceptable Must be treated JUST LIKE an error in a hospital Take no prisoners 37

38 The Primary Understanding A missing ampule of a scheduled drug can no more be tolerated in the EMS world than it would be in a hospital Enlightening Discoveries made along the way DEA investigator said that fentanyl had no place in the prehospital arena DEA 222 form 3 rd copy Authorizing vs. Ordering Entity Registration of drug boxes that don t return to a central station is required This activity is State by State Meeting Buildings with are registered, DEA not the ambulances November Distributor Registration 3, 2010 required DEA 222 forms for restocking rigs, and forms stay with the drugs Dallas, Disposal policy TX Double-locking NOT DEA policy There s No Hurry 38

39 Waste or Reverse Distribution? Compounding the Problem Medications Shortages and Their Effects on Emergency Medical Services 39

40 Rolling the Dice You have extra fentanyl on one ambulance and not enough on the other: What to do??? Where are the Shortages? Fentanyl Morphine Midazolam Droperidol Ketamine Etc etc etc 40

41 Ruminations upon Closing An Ethical Imperative You do people a favor when you HELP keep them honest Thoughts upon going home Look at your policy Ask about the inventory Get buy in Share war stories Keep an eye on the store! Multiple registration is probably headed your way, so think about staff support! 41

42 Psalm 39:6: Verily mankind walketh in a vain show. May you live in interesting times Crisis is DANGER mixed with opportunity Always create the crisis on YOUR timeline! Thank you so much for your kind attention! 42

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