Effective: 08-31-24
Supersedes: 12-08-21
Purpose:
As a licensed Advanced Life Support provider, Brewster Ambulance Service is required to carry a variety of scheduled and closely regulated medications. In accordance with state and federal guidelines, adherence to policies and procedures this policy will insure the proper maintenance and security of these agents.
Policies may differ from region or hospital facility. Policies in this section are comprehensive policies, which generally apply company wide. However, there may be additional policies specific to certain systems or individual hospitals.
Policy:
It is the responsibility of Brewster Ambulance Service personnel who are certified in accordance with applicable state laws and regulations to maintain proper security measures for all controlled substances utilized in performance of their duties. This responsibility cannot be delegated or assigned to personal whose level of licensure, certification and training does not provide for the administration and possession of controlled substances and devices.
The following equipment and procedures will be deployed during Brewster Ambulance Service EMS operations in accordance of department of public health office of emergency medical services statewide treatment protocols.
Employee Responsibility to Report Drug Diversion
Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of the Drug Enforcement Agency and Brewster Ambulance Service that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. In the case of Brewster/EasCare Ambulance Service, this notification may be made to any Supervisor or Manager. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining continued employment. (See: 21 CFR 1301.91)
System Components
Each advanced life support vehicle will have a medication system which is made up of several components.
· Master medication box
· First aid medication box
· Controlled substance sealed container
· Medication and narcotics logbook
· Combination padlock
· Locking of System
Each master medication box will be within a locked cabinet on the vehicle. For vehicles that do not have a locking cabinet the box will be secured in a safe location in the vehicle.
Each paramedic staffing the vehicle will have the access code for the combination lock to open the master box. Supervisor vehicles may have an additional locking storage location with a specific code. In addition, the narcotics container within the master box will be sealed with an identified number seal which can be removed when the medications are needed for use. If one of the partners is not of a level of certification that authorizes access to controlled substances, they will not be provided the lock code.
Medication Lists
The Department of Public Health Office of Emergency Medical Services approved list of medications will be followed. Any of the following medications or medication classes, not currently part of the EMT Paramedic Statewide Treatment Protocols, may be maintained if initiated at the sending facility, and can only be titrated through specific IFT protocols and by on-line medical control.
· Aminophylline
· Analgesics
· Anticonvulsants
· Antidotes
· Antidysrhythmics
· Antihypertensive agents
· Anti-infectives (e.g., antibiotics, anti-sepsis)
· Benzodiazepines
· Blood products
· Chemotherapeutic agents
· Electrolyte infusions
o Potassium, limited to 10 mEq / hour
o Magnesium, maintenance infusion limited to 2 g / hour
· Glycoprotein IIb / IIIa inhibitors
· Heparin
· 3% Hypertonic Saline
· Insulin infusions
· Intravenous steroids
· Mannitol infusions
· Octreotide
· Paralytics
· Parenteral nutrition
· Proton Pump Inhibitors
· Sedatives
· Standard IV infusion fluids (including 10% Dextrose)
· Thrombolytic agents
· Vasodilators (including all forms of Nitroglycerin)
· Vasopressors
Note: All medication infusions other than standard crystalloids and blood products must be administered by IV infusion pump. [Massachusetts STP Appendix A2: v 2020.2]
City of QUINCY ALS 911 Vehicles (12/08/21) will be stocked with:
· Fentanyl 800 mcg.
· Midazolam 20 mg.
The minimum PAR levels are:
· Fentanyl 400 mcg.
· Midazolam 12 mg.
Controlled substances will be used in accordance with the Statewide Treatment Protocols as clinically indicated. Following the completion of the call, the inventory will be tallied and a new seal applied to the narcotics box.
· If the usage results in the narcotics box being below PAR and all of the usage occurred on one call, the crew completes the PCR in a timely manner and then proceeds to the appropriate hospital pharmacy to restock the narcotics box.
· If the usage results in the narcotics box being below PAR from multiple calls with different crews, the on duty crew should contact FS-1. FS-1 will coordinate meeting the crew with all of the necessary run reports so that the crew can proceed to the appropriate pharmacy and completely restock the narcotics box.
· If the usage results in the narcotics box remaining at or above PAR, the lead paramedic emails FS-1 (QuincyFieldOPS@BrewsterAmbulance.com) with the truck they are on, the run number of the call, and what controlled medications were administered. FS-1 will pull the report and maintain in the Supervisor’s Office.
FS-1 will monitor narcotic usage daily and will proceed to an appropriate pharmacy (usually South Shore Hospital) when the supervisor determines systemic restock is indicated. When the Supervisor obtains the medication from the pharmacy, (s)he will coordinate to meet each truck in need of replacement. The supervisor will provide the medication to the crew, conduct an audit of the narcotics box and observe the crew reseal the narcotics box.
Storage / Documentation
The narcotics kits are housed in a military grade translucent plastic container. Within the container is scheduled contents along with a fillable drug card which is visible though the container without disturbing the integrity of the sealed unit. The container along with the card allows the clinician to not only view the integrity of the pharmacology but also allowing for expirations and quantities as well. (See Images)
The container is sealed and numbered with a serial number that corresponds to the accompanying drug log. The seal numbers will be recorded in the drug log at each change of shift.
At the beginning of each shift, the following events will take place:
1. Ensure the appropriate drug box and corresponding narcotics kit are with the assigned vehicle.
2. Ensure that the appropriate tag number corresponds with the log book from the previous shift.
3. The box should be inspected for tampering/breakage. Visually inspect contents and look for damage noting integrity of vials. Check the seal for signs of tampering such as scratches, discoloration and signs of glue used to reconnect seals.
4. The seal used should be specific to narcotics storage and not one of the routine seals used for cabinets, bags etc.
5. A completed narcotics card should be visible through the translucent container indicating the date, time, unit number, contents of the box, expiration dates, concentration totals of each scheduled medication, paramedic or supervisor signature and the corresponding seal number securing the module.
6. The date/ time, start/end seal number, names and signatures of clinician, quantity of controlled substances and the expiration dates should be documented in the drug log.
7. The oncoming crew should print and sign their name with the appropriate time.
8. The off-going crew should print and sign their name with the appropriate time at the end of their shift.
Inventory of Medications at Shift Change / Log Book
Additional medication such as Cyanokits stored in a different area should be inspected as well for integrity of the medication, associated supplies, expiration dates etc.
· The medication log is a bound book with consecutively numbered pages. Each page has three sections.
· The top section of each page is an inventory list of medications carried with par level indicators and their expiration dates.
· The bottom section of the page is for the secondary first in drug box the rear section of the page is for the controlled substance usage.
· The front cover of the medication accountability log will indicate the company and unit it is designated for.
· The inside cover will contain detailed instructions needed for completing the log.
Updated Electronic Option (10/1/21)
Progress will be made for an electronic drug log for completion by the paramedics. Forms and checkouts will be completed through TraumaSoft and submitted for review and or supervisory audit. Controlled substance log books will be kept in the drug box to comply with drug control program and DEA requirements. This log will also compliment the EPCR with controlled substance use for patients.
Replacement Log Books
Replacement log books will be distributed monthly to each base location for each dedicated advanced life support unit. Previous logs will be collected and returned to Brewster Ambulance Service for auditing purposes. Logs will be kept on file for a period of time which is compliant with statewide regulations.
Completing a New Page in the Log
New section and the log must be completed whenever any of the following circumstances occur.
· When any member of the crew changes either at the end of a shift or under any other circumstances that replaces a crew member.
· Exchange of outdated controlled substances or exchange of controlled substances one containers damaged
· Whenever a seal is broken on controlled substance sealed container either intentionally or accidentally
· A crew member makes a transcription error while completing an entry in the log
· Any supervisor audits
· When initially supplying new individual medication or entire set of medications the origin of such medications should be noted in the log by a supervisor.
Documentation Errors
If a crew member makes a transcription error during a log entry a single line will be drawn through the entry leaving the entry legible but indicating an error. The crew member ’s initials should be placed in the strikethrough indicating the provider who made the error. The crew member will then start a new page in the log if needed or unable to read.
Supervisor Audits
Whenever the seal of a controlled substance container has been broken or removed in cases of narcotics being used appropriately, the designated paramedic on the unit is able to complete the audit of the controlled substance container. If an additional audit is needed for tampering or breakage the crew must immediately notify dispatch to access a field supervisor. This audit must be completed within a reasonable timeframe if the seal has been broken or removed. Supervisor audits should also be done periodically. Any audit done on the medications should be documented in the drug log.
Controlled Substance Usage
When controlled substances are utilized during a patient encounter, the following information should be documented in addition to the encounter form in the drug log.
1. The run number
2. Date and time the medication was utilized or exchanged
3. Medication used
4. Dose administered
5. Amount wasted
6. Witness name
7. The new control seal number
8. Completion of EPCR
Documentation of Waste
A Brewster/EasCare Paramedic, or nurse, physician or pharmacist at the receiving hospital at the receiving hospital must be present to witness the wasting of any opened but unused portion of any scheduled medication. This person will be asked to sign the controlled substance usage section confirming the unused medication was properly wasted and that the container was resealed with a new numbered seal. Wasted or broken vials or ampules of scheduled medications must be returned to the hospital facility as well as the controlled substance sealed container.
The controlled substance usage section must be completed and countersigned by a witness to the breakage in the container will be resealed with the new numbered seal. The waste or breakage must be reported to a paramedic supervisor either directly or via the communication Center and then inventory and documentation requirements must be met.
Drug Incident Reporting
A breach of security requires immediate actions. At a minimum it requires the filing of an incident report and investigation by a paramedic supervisor. Any discrepancies of the container, seal or contents should involve a paramedic supervisor for inspection and completion of a drug incident form provided by the drug control program. This information collected will include the following:
· Date
· Preparer
· Title
· Phone
· Facility information
· Facility type
· Date and location of loss
· Incident type
· Drug and narrative associated with the incident.
Required Action Following A Security Incident
In the event of a medication security incident, the following steps shall be taken immediately:
· The paramedics responsible for the unit involved contact dispatch or operations by telephone to arrange a verbal report to the paramedic supervisor on duty. The director of operations and/or the Advanced Life Support coordinator must be notified immediately.
· Following the verbal report, each crew member must complete a separate incident report this can be done either written or electronically.
· The director of operations and advanced life support coordinator must collate all incident reports and complete a final report documenting their investigation of the incident and all actions taken.
· In the case of a breach in the security lock code, a separate lock code will be issued until the appropriate measures have been taken. Depending upon the scope of the incident locks may have to be replaced.
· Depending on the severity of the incident the advanced life support unit may be taken out of service until the initial investigation is complete.
If a drug security incident involves loss or theft of controlled substances further action and notifications are required:
· Report must be made by telephone or in person to the pharmacy director at the hospital which supplied the medications. During normal business hours this would be handled by the Advanced Life Support coordinator. If delegating the reporting task to the Advanced Life Support coordinator would result in an undue delay, the report will be made by an advanced life support supervisor.
· The appropriate state agencies must be notified- the Massachusetts Department of Public Health Division of Food and Drug.
State agencies noted above are open on weekdays during normal business hours. If the incident takes place after hours Notification can be made via fax or it can wait until the next business day. Following a verbal report to comply with instructions for a formal written report. The Advanced Life Support coordinator will be responsible for contacting the appropriate state agencies and in coordinating the filing of any and all reports required.
As with any medication security incident the director of operations and the Advanced Life Support coordinator must collate all incident reports and complete final report documenting their investigation of the loss or theft, all actions taken in all notifications made.
Reporting to Law Enforcement Authorities
If it appears that the loss of drugs was due to theft, notifications to the local law enforcement authorities in the community where the theft took place will be made. This will be done in cooperation with the hospital that supplied the medications. Depending upon the scope of the incident, officials at the division of food and drug may involve State Police officials who are tasked to that agency for field investigations. Drug testing may be part of the investigation of any suspected drug diversion or theft. Personnel will be asked to submit to a drug test to screen for the drug in question. Their test will not be of any accusatory nature, rather it will be routine request as part of a comprehensive investigation.
Compliance with Medication Security Procedures
Failure to adhere to company
policies and procedures in regard to medication security can be considered
serious infractions since they may also be a violation of state and federal
regulations. Inadvertent documentation errors are not considered
serious medication security incident, however repeat occurrences will
lead to progressive discipline in accordance with personnel policies.
Such infractions may also constitute a violation of state or federal laws
and regulations therefore jeopardizing an employee ’s
state certification status.
Brewster Ambulance Service is a licensed ambulance provider and holder of a controlled substance registration and required to report all such infractions including the personnel involved.
Incidents involving the loss or theft of medications may result in an employee being placed on administrative leave while the incident is being investigated by Brewster Ambulance Service and law enforcement authorities locally.
Unit Out of Service
The following procedures must be followed when the unit is not in service at the paramedic level.
· The medication log by the off going paramedics will note the phrase “unit out of service” in the signature blocks where oncoming paramedics would normally sign.
· The drug system must be removed from the ambulance and secured in a key or combination lock cabinet within the ambulance station.
· Each key or combination to the system lock that is used to secure the lock stations cabinets while the system is out of service shall be stored in a locked box at the station.
· The names of all individuals with access to the locked key box will be forwarded to the advanced life support coordinator and updated regularly for tracking purposes.
· Access to the locked station cabinet must be restricted to paramedic certified personnel only.
· When the unit returns to service, the oncoming crew will perform a normal inventory and inspection utilizing the medication log specific to that medication system. They will note the phrase “unit back in service” in the signature blocks where the off going paramedics would normally sign.
Transport of Medications Across State Lines
When controlled substances are needed for a transport outside of the Commonwealth of Massachusetts, additional medications may be requested to facilitate the transport. Information that will be provided during the transport is the current ambulance service license food and drug license list of all Massachusetts department of public health office of emergency medical services approved medications and authorization for transport from the service medical director.
Controlled Substance Registration
Brewster Ambulance Service is to provide an updated copy of the Massachusetts controlled substance registration to the affiliated pharmacies departments annually or on or before the expiration date that registration. In addition, the medical director ’s federal controlled substance registration for Brewster ambulance service locations should be forwarded when renewed. All controlled substance registrations will be properly mounted at each base location indicating a valid registration with the drug control program.
Out of State Compliance for Medication Storage
Brewster Ambulance Service may have vehicles that are licensed in multiple states. For those vehicles licensed in another state, the following conditions will apply for compliance. Medications authorized by other states such as Rhode Island or New Hampshire will be kept in a separate container. This container will be clearly labeled with the applicable State. When these medications are not in use they will be stored in a locked cabinet within the base area. These medications will be stored in conjunction with additional equipment required for the State in which the ambulance is assigned. These medications and additional pieces of equipment may only be removed from the locked cabinet by authorized certified paramedics within that operating State. Any additional scheduled medications such as Midazolam will be stored within the medication security system highlighting the additional par levels required for that State.
