As the EMS industry struggles to endure a period of time where supplies of all classes of emergency medications have been short, and where patient care needs have become more frequent, leaders are seeking long-term management strategies.
These strategies will have to allow efficiency, flexibility, accountability and regulatory compliance in the use, storage and planning for important medications.
Hospital strategies for achieving these goals have resulted in the widespread use of electronic dispensing systems, which have dramatically improved accountability, planning capability and staff satisfaction, while reducing medication loss.
This has occurred with a significant expense in placing the machines, which is offset by the reduction in staff time (mainly nursing) in accounting for medications.
Many responders have come into contact with these dispensing systems as hospitals use them more frequently to track supplies and disposables.
There are ongoing needs to manage supplies of controlled substances, to fulfill regulatory mandates and make sure these medicines are available for critical patient care, and not diverted for criminal purposes.
Today, there are opportunities to apply inventory and dispensing management systems for use with all forms of medications in EMS.
Inventory management systems and electronic assistance can be applied to all processes in the tracking of very important assets. Management systems can be designed and implemented to control:
- Wholesale diversion of medications in the supply chain (Step 1)
- Employee diversion of big quantities of medications (Step 2)
- Theft by non-employees (Step 3)
- Employee diversion of smaller quantities by an individual (Step 4)
- Accounting for the appropriate use of medications in this age of shortages (Step 5)
Inventory management in EMS
The purpose of the program is to provide effective systems for the tracking, accountability, administration, waste, disposal, restock and record keeping of all medicines and controlled substances utilized for EMS patient care.
These requirements must particularly account for the security, handling, maintenance and utilization of the medicines that are known as controlled substances.
Controlled substances are medicines that are defined under Title 21 United States Code (USC) Controlled Substances Act 802(6).
Under this Federal law, a controlled substance is a “drug or other substance, or immediate precursor, included in schedule I,II,III,IV, or V of part B of this Act.”
In EMS, these medicines are used to control pain, provide sedation, stop seizures and facilitate the management of bone and joint injuries. Because these medications have an abuse potential, they require specific tracking, documentation, security and controls.
Under both Federal and state laws, these medicines are managed by the Drug Enforcement Administration (DEA), which has strict requirements that pertain to storing, dispensing, administering and record keeping requirements for controlled substances.
The rules of this agency often define loss of these medicines as “diversion,” so many of the programs for reducing thievery, sale, or accidental loss are referred to as diversion control.
The license that allows an EMS service to utilized controlled substances is generated by the DEA, and is assigned to the agency’s medical director, at a single physical address. That address is the only site where controlled substances can be delivered, and therefore it serves as the base location for the logistics and inventory management program to begin.
Traditionally, EMS agencies have done controlled substance inventory using a system of forms and logs.
A Master Control Log serves as the record of all controlled substances in EMS possession. This log tracks all medications from the date of receipt from the vendor, through the issuance to the field units, to administration and/or wasting and/or removal from the system.
The agencies then use Controlled Substances Accountability and Tracking Forms to manage the medicine through each step in the physical movement and checking of inventory. The forms have traditionally been all in hard copy, but modern systems will allow these forms to exist in a digital version on a computer.
Using these forms and logs, a chain of custody of controlled substances is maintained.
Stepwise logistics
Problems, and therefore solutions, can be addressed using electronic enhancements to a manual system. For some years, the logistics vendors that deliver the medication have used tracking systems that can locate a shipment, account for each individual who accounted for the shipment and provide a record of an individual package.
Many of these now have embedded tracking chips, which can geo-locate any stolen or diverted shipments.
Step 1 is completed when the medication shipment is received from the shipping agency, and the quantity, integrity and identity of the medication is verified as the same as specified by the medication vendor.
The logistics division of the EMS agency assumes responsibility with the intact receipt of the shipment. Video-recording systems may be utilized as the first level of accounting for the receipt of an intact medication shipment and placement in a secured safe.
The Logistics Section will maintain control of the largest quantities of controlled substances, typically in a system that is approved and inspected by the state Department of Pharmacy or Health.
The systems for control at this stage will include physical elements that deter theft, and account for all individuals who have access to the safe holding of the medicines. State requirements will typically specify that the safe and the structure containing the safe are under environmental controls for heat and humidity, have steady power supplies, and have alarm systems for all hazards.
Loss of medication in this Step 2 of management is prevented or minimized using a set of physical controls:
- Medicines must be stored in an approved safe in a secured building, under double lock. Often the building, room and safe has restricted access to only approved personnel, whose access is recorded using individual key fobs or other electronic identification systems.
- Most EMS agencies have independent tracking logs for each controlled substance in the safe. These logs will record all movement into and out of the safe must be tracked in the appropriate tracking log, and retained for a minimum of 7 years.
- Alarm systems will be in place to record unauthorized access to the building or the safe, loss of power to electronic systems, fire and smoke, and loss of environmental integrity.
Step 2 prevention is able to minimize the theft of larger quantities of medications to outside persons who break into the storage area, but is primarily targeted toward the diversion of larger quantities of medications by the agency’s own personnel.
The management of controlled substances that are moved out into the field for patient care requires the most flexibility in design and implementation.
Once moved out of the central safe, the supplies typically are in smaller quantities. The tracking system must record the chain of custody until each unit of the medication is used in patient care, wasted or returned at its expiration date.
A chain of custody system will use forms, barcodes, computer algorithms or video-recording to generate the map of the intact vials of medications into a portable drug box of some type.
That box is then maintained in a multiple lock system so that it cannot be taken by a person who is not a paramedic in the EMS system, but can be accounted for by the EMS providers (Step 3).
The chain of custody begins when the medication vials are removed from the central safe, and the individual medication lot numbers and expiration dates noted by the paramedic provider who assumes control of the medication.
The chain of custody is another delegation of authority to paramedics to utilize controlled substances in prehospital care.
As such, each paramedic who comes into contact with the medication box must document the integrity of the box, and verify that medications are not reaching the expiration dates. Each EMS system has rules that relate to the physical locations where the boxes can be moved, how they are secured in response vehicles, and how they will be accessed when it is time for patient care.
Often the entire drug box is subject to a routine shift overlap process, when the off going paramedic and on coming paramedic will both visually check the box and verify the count, integrity and expiration date of all medicines in the box.
Security of the medication box in the vehicle and the field is the responsibility of the one or two paramedics assigned to the unit.
Some systems use an electronic key fob to assist in this individual accountability system, such as to access a mobile drug safe in the EMS vehicle.
There are a growing variety of electronic systems to assist this process, and enable the paramedics to efficiently carry out their responsibilities for security checks, tracking, compliance, documentation, and finally the use of the medication.
Final use may include the provision of some of the unit dose to the patient and some that is wasted. Taken together, these systems allow the management of controlled substances in the hands of individual paramedics, and minimizes the potential loss of diversion of medication by an EMS agency employee (Step 4)
As EMS comes to use electronic versions of a patient care report, there is an expanding number of functions that the portable computers may be programmed to accomplish.
Those may automatically complete the chain of custody process, facilitate the use of bar codes or other inventory tracking systems, record the details of patient need and response to the medication, and assist in the correct use of medication, despite the challenges of drug shortages.
Behind the provider use, the managers of the EMS agency may be using digital systems to provide the details needed for tracking the needs for medications, and for complying with budgets and regulatory needs.
Managers have primary responsibility for DEA compliance, and the master log should facilitate that process. The managers must order the appropriate amount of all medications, and manage the inventory so that medicines are available for care but do not get wasted as they reach expiration dates prior to use.
This budgeting and forecasting function is a critical application of the overall drug inventory management system (Step 5).
Medication shortages and the inventory system
Recent unprecedented, unexpected and unplanned shortages of emergency medications have resulted in a quickly expanding set of problems for EMS agencies.
The causes of this shortage are poorly understood, but the manufacturers and the Federal agencies that oversee drug supply and manufacturing practices (FDA and DEA) have been at odds for the past few years over safe manufacturing and quality processes.
Medication shortages are affecting many groups, but the emergency care system is particularly at risk for patient safety issues. The inventory management system will assist EMS agency leaders to plan for the impact of drug shortages, and may be able to provide point of care assistance to paramedics that have to deal with the shortage.
Drug shortages among local EMS providers may force the system and the paramedics to use substitute medications that are not in the usual practice. Without access to the preferred or most clinically appropriate drug treatment, EMS personnel may be forced to use alternatives that are less effective and may have an increased risk of adverse outcomes.
For example, if pain medicines are restricted and only fentanyl is available, paramedics must be advised that this will be the substitute pain medication, and that the usual doses are far less then with morphine.
EMS leaders are putting safety cards in their medication boxes, or safety notices on the EMS computers, to give paramedics an immediate visual safety prompt.
A terrible outcome of the shortage of emergency medications is if patients are harmed because they have received dangerous doses or forms of medications. Patients are also harmed if they receive no medication at all, because the paramedics are not comfortable with the unfamiliar medicines or subject to a cumbersome documentation system that discourages the use of medications.
Summary
As the health care industry struggles to endure shortages of emergency medications, effective information technology strategies will support efficiency, flexibility, accountability and regulatory compliance in the use, storage and planning for these important drugs.
The widespread use of electronic dispensing systems in hospitals has dramatically improved accountability, planning capability and staff satisfaction, while reducing medication loss.
There are ongoing regulatory mandates to manage supplies of controlled substances, to make sure these medicines are available for critical patient care, and not diverted for criminal purposes.
Inventory management systems and electronic assistance can be applied to all medication control processes, and extensions of the program can improve the tracking of all important EMS assets.
