Controlled Substance Guidelines Revised September 2015 Version 2.0
Intent The following policy will define the usage, waste and tracking of all controlled substances within the Galveston Area Ambulance Authority System. The goal of the policy is to ensure that the chain of custody, storage, use and accountability of all controlled substances is monitored in order to provide end to end monitoring of said substances in compliance with all regulatory requirements. The procedures contained in this document constitute guidelines only, GAAA Administration cannot anticipate all extraordinary circumstances that may occur during patient care and the administration of narcotics. Unusual events will be investigate and addressed on a case by case basis, reviewed by the GAAA Administration, Quality Assurance/Clinical Coordinator, and Medical Director to ensure necessary safeguards are in place to maintain the chain of custody required by Federal and State Rules & Regulations. Controlled Substance Guidelines Page 2
Table of Contents Controlled Substance Process Overview... 4 Administrative Responsibility... 5 Drug Enforcement Administration & Texas Department of Public Safety CSR... 5 Controlled Substance Ordering... 6 Controlled Substance Storage & Dissemination... 7 Receipt of Completed Usage/Waste Forms... 8 Disposal of Expired Controlled Substances... 9 Controlled Substance Monitoring & Audit... 10 Supervisor & Field Staff Controlled Substance Guidelines... 11 Chain of Custody... 11 Late Calls & Posting Assignments... 12 Peak & Special Event Units... 13 Non-Emergency Transport Units... 14 Administration & Replacement of Controlled Substances... 15 Expired Controlled Substances... 16 Reverse Disposal for Expired Medications and/or Compromised Security Seals... 17 Controlled Substance Guidelines Page 3
GAAA Medical Director Controlled Substance Oversight GAAA Administration Licensing, Ordering, Tracking & Disposal of Controlled Substances DPS Controlled Substance Registration Certificates USDOJ/DEA Controlled Substance Registration Certificates DEA Form 222 Controlled Susbtance Order Form Medication Ordered UTMB In Patient Pharmacy Authorized Receivers EMS Administrator Operations Manager Supervisor Received ID Number & Tracking Form Assigned Medication Entered into Tracking Logs Supervisor Receives Medication & Form Supervisor Daily Log Updated Supervisor Daily Log Updated Vial & Form Assigned to Field Unit Field Unit Log Updated Medication Administered/Wasted Medication Expired Medication Broken/Lost/Stolen Administered/Wasted/Expired Tracking Form Updated Replacement Issued Supervisor Replaces Medication & Form Broken/Lost/Stolen Tracking Form Updated Supervisor Notified Incident Report Completed All Forms Forwarded to Administration Logs Updated & Forms Filed QA & Compliance Review Controlled Substance Guidelines Page 4
Galveston Area Ambulance Authority Administrative Responsibility Ordering of narcotics, storage and dissemination of medications will be handled by the EMS Administrator. This section will outline the procedures by which controlled substances will be procured, tracked, securely stored, assigned to the field and usage recorded. GAAA Administration Controlled Substance Guidelines: Drug Enforcement Administration & Texas Department of Public Safety Controlled Substances Licensing: 1. GAAA Medical Director will authorize EMS Administrator to procure, store, track and disseminate controlled substances as needed, within State & Federal guidelines. 2. Site licensing will be performed as required by state and federal laws. GAAA Administration will handle licensing applications for the following stations/locations: a. GAAA Administration Offices b. Galveston Island Stations c. Jamaica Beach Station d. Hitchcock Station e. Bacliff Station 3. GAAA Administration will procure Texas Controlled Substances Registration Certificates a. Annually renewed prior to certificate expiration date 4. GAAA Administration will procure USDOJ/DEA Controlled Substance Registration Certificates a. Renewal every three (3) years prior to certificate expiration date 5. GAAA Administration will procure DEA Form 222 for ordering scheduled narcotics 6. Expired Controlled Substance Registration Certificates will be destroyed no less than one month after expiration 7. Voided, cancelled, or damaged DEA Form 222 will be returned certified mail by GAAA Administration to DEA Regional Division Office Diversion Department, as required by law. a. Address: U.S Drug Enforcement Administration Houston Attention: Diversion Department 1433 West Loop South, Suite 600 Houston, Texas 77027 Controlled Substance Guidelines Page 5
Controlled Substance Ordering 1. Controlled substances will be ordered by EMS Administrator from UTMB Galveston Inpatient Pharmacy by fax. 2. Controlled substances will be received by EMS Administrator or Supervisor as permitted by the Medical Director. 3. EMS Administrator and/or Supervisor will utilize DEA Form 222 when receiving controlled substances from UTMB Pharmacy following the procedure as indicated on the reverse side of the form. 4. EMS Administrator and/or Supervisor will verify the amount of packages ordered with the amount of packages received making note of this number and dating as required on the DEA Form 222. 5. DEA Form 222 Purchaser Triplicate Copy will be kept on file with printed pharmacy receipt regarding the delivery of controlled substances from UTMB for a period of no less than two (2) years from the date of purchase. a. After no less than two (2) years have expired, these documents may be destroyed as allowed by law. 6. The received pharmaceuticals will be transported directly to the GAAA Administration Office by the EMS Administrator and/or Supervisor where they will be recounted, logged into bulk supply and signed for according to the following guidelines. Controlled Substance Guidelines Page 6
Controlled Substance Storage & Dissemination 1. Upon receipt of controlled substances into bulk supply, two (2) GAAA Administrative persons will sign for the medications verifying the number ordered and shipped on the UTMB pharmacy printed receipt. 2. All medications will immediately be assigned a unique identification number consisting of the following: a. Alphabetical designation utilizing the first letter of the name of the medication as shown. Example: Fentanyl (F), Diazepam (D), Morphine (M), Versed (V) and Geodone (G). b. Annual designation utilizing the year the medication was procured. Example: 2015 c. Four (4) digit numerical identifier beginning with 0001 after January 1 st of every year for newly procured medications. This identifier will be sequential for the particular medications that were procured within the same calendar year. d. Complete identification number example: Fentanyl would be shown as F2015-0001 3. Each individually identified vial or ampoule will have a designated usage and waste form that will follow each medication into the field until it has either been administered to a patient or the medication has expired. 4. A log containing each unique identification number and associated medication name, lot number, expiration date, date procured, and associated dissemination and usage information will be kept by the EMS Administrator to track and log the receipt of the medications, the end usage and expiration of each medication. 5. Bulk supply controlled substances will be housed in a double-locked secure location at the GAAA Administrative Office until assigned to the Supervisor s supply safe along with the associated usage and waste form. 6. The EMS Administrator will perform a face-to-face delivery to the on-duty Supervisor with the medications being requested. a. The use of intermediaries will not be allowed 7. Signatures for the receipt of the medications will be obtained along with a signature from the EMS Administrator. Controlled Substance Guidelines Page 7
Receipt of Completed Usage/Waste Forms 1. Controlled substances Usage and Waste Forms will be returned to the Supervisor for replacement medications in person. a. The use of intermediaries will not be allowed 2. Completed forms will be delivered by the Supervisor to the EMS Administrator where they will be inspected for completion and appropriate signatures. 3. Information from forms will be entered into the GAAA Administration Narcotic Database. The forms will then be filed in order of the medication name and date administered. 4. Usage and waste forms will be kept on file for a period of no less than two (2) years from the date of final disposition. Controlled Substance Guidelines Page 8
Disposal of Expired Controlled Substances 1. Expired controlled substances will be forwarded to an approved facility for destruction as approved by State & Federal regulations. 2. Receipt of this procedure will be kept on file for a period of no less than two (2) years from date of destruction. Controlled Substance Guidelines Page 9
Controlled Substance Monitoring & Audit 1. Monthly audits of the logs, daily chain-of-custody forms and a physical inspection of every controlled substances in inventory or circulation will be performed by the Quality Assurance/Clinical Coordinator. 2. Discrepancies will be reported to the EMS Administrator, Medical Director and Galveston County Health District Risk & Safety department. 3. Reports tracking the usage statistics for each employee will be the responsibility of the Quality Assurance/Clinical Coordinator, and will be reported quarterly or as needed to the EMS Administrator and Medical Director. Controlled Substance Guidelines Page 10
Galveston Area Ambulance Authority Supervisor & Field Staff Responsibility GAAA Supervisor & Field Staff Controlled Substance Guidelines: Chain of Custody 1. Controlled substances will be signed for at the beginning of each shift with both the off-going and oncoming Team Captains present. 2. The on-coming Team Captain or other designated personnel will be responsible for the controlled substances. In the event that the controlled substances are stored in a lockbox, the Team Captain will be responsible for maintaining control of the key on his/her person. 3. In situations where it is unclear who will be responsible for the controlled substances (both crew members are Team Captains or the unit is double Paramedic) the crew member physically possessing the controlled substance lockbox will be responsible otherwise, both crew members will be responsible for the controlled substances stored in the apparatus safe. 4. The daily chain-of-custody sheet will reflect the number of narcotics counted, documenting each of the unique numbers assigned. 5. The on-coming Team Captain will sign in the on coming space as receiving the narcotics and the Team Captain leaving signs as off-going to document transfer of medications. Personnel will perform a face-to-face release at all times. 6. When a situation occurs that requires the Team Captain to leave work during the shift, the Team Captain and the Attendant will count and sign for the narcotics before the Team Captain leaves the station. Controlled Substance Guidelines Page 11
Late Calls & Posting Assignments In the event that a medic unit is assigned an emergency response or post assignment near the end of shift before transfer of the narcotics can be completed as described above or the oncoming Team Captain arrives on the scene of an assigned response and assumes patient care, the following guidelines will be followed: 1. The Team Captain will complete the sign-in sheet as soon as possible after the call is completed with his/her attendant partner as the witness. Signatures go in the on coming signature box to ensure chain of custody and document the Incident Number of the late call or the time the post assignment was assigned in the off going signature box on the tracking form. This will indicate to the Quality Assurance Department as well as the Supervisor why the signature is missing and that disciplinary action is unnecessary. Controlled Substance Guidelines Page 12
Peak & Special Event Units 1. GAAA employees assigned to a Peak Unit (Team Captain & Attendant) or covering a Special Event, when a face-to-face exchange of the controlled substances with an off going crew is not practical, the narcotics will be received from and counted with a Supervisor, then both signatures will be recorded with the Supervisor in the off going and accepting personnel in the oncoming section. 2. At the end of the shift this process will be repeated with the medications being returned to the Supervisor for placement back into the Supervisor safe. At this time both the employee and Supervisor will again count the medications and sign with the Supervisor in the on coming and the medic in the off going slots. The controlled substance log will remain with the respective medications until which time they are placed back in service on a unit. Controlled Substance Guidelines Page 13
Non-Emergency Transport Units 1. For the usage on occasional non-emergency ALS/MICU transports, the process will be the same as Late Calls & Posting Assignments. There will be no need for non-paramedic staff to access the safe or inventory the contents. 2. The Quality Assurance/Clinical Coordinator and/or the Supervisor will handle a monthly visual inspection of the medications for tracking and audit purposes. 3. Non-Paramedic staff will not have authority under medical direction or protocol to administer the medications however. 4. In the event a medication is used for administration, lost, stolen, or there is breakage to a vial/ampoule, the person administering the medication or discovering the anomaly will adhere to the guidelines as indicated in this document on the proper reporting methodology. Controlled Substance Guidelines Page 14
Administration & Replacement of Controlled Substances 1. Controlled substances may be administered by GAAA Paramedics who are duly authorized by the Medical Director and by protocol in the Clinical Operating Guidelines. 2. A controlled substance administered outside of these guidelines or in the absence of appropriate direction from online medical control is considered Diversion of Controlled Substances and will be reported to law enforcement authority. 3. Paramedic Students are not allowed to administer controlled substances under any circumstances. 4. After administration of a controlled substance, the Paramedic administering the medication will complete appropriate fields of the Controlled Substance Use and Tracking Form. 5. The Paramedic will also document the control number from the medication in the control field inside of the intervention in ESO. 6. Any medication remaining after patient administration will be wasted and witnessed by a minimum of two GAAA personnel at the receiving facility immediately after release of patient care and the associated Controlled Substance Usage and Tracking Form completed. Until this is accomplished, the remaining medication will be locked in the apparatus safe or lockbox. 7. Any medication not administered to a patient after opening will be wasted into an approved sharps container. 8. With any medication administration or inadvertent wasting, the appropriate Controlled Substance Usage and Tracking Form will be completed and turned into the Supervisor. 9. Supervisor swill make a copy of the Controlled Substance Usage and Tracking Form for the replacement medication as record of the medications location, and keep it in a binder with the supervisors bulk supply. 10. Only GAAA employees are authorized to dispose of, and witness the disposal of, an unused narcotic and their name and signature will be documented on the replacement form. 11. The unique tracking number assigned to the medication will be documented in the epcr. 12. Senior Team Captains assigned to a shift may replace narcotics to a medic unit in the absence of a Supervisor after all paperwork has been documented. 13. A Supervisor Unit may remain in service even though their controlled substance supply is depleted. Controlled Substance Guidelines Page 15
Expired Controlled Substances 1. All controlled substances will be checked daily for expiration dates and may be administered through the end of a month, unless the expiration date specifies a specific date. 2. Medications nearing their expiration date will be administered first in appropriate situations as controlled substances cannot be returned or exchanged. 3. A Supervisor will be contacted for replacement before the medication expires. Controlled Substance Guidelines Page 16
Reverse Narcotic Disposal for Expired Medications and/or Compromised Security Seals To ensure compliance with Federal DEA and State Laws, GAAA will not dispose of expired narcotics at outlying stations/locations when the Tamper Resistant Seal is intact. The procedure for replacing expired narcotics will be as follows: 1. Contact your Supervisor and advise them you have narcotics that are expired/expiring. 2. The expired controlled substances will be exchanged with the Supervisor with the Tamper Resistant Seal Intact and completed paperwork. The Supervisor will return the expired medications to GAAA Administration for disposal according to State and Federal regulations. 3. Controlled substances that are discovered with broken seals will be exchanged as they are with an incident report attached to the Controlled Substance Usage and Tracking Form describing how you found the medication. These medications will be wasted appropriately with the personnel discovering the anomaly and a supervisor witnessing the waste. Controlled Substance Guidelines Page 17