In 2015, the Los Angeles County (CA) Fire Department (LACFD) was informed that county hospitals would no longer provide controlled drugs to prehospital providers under the pharmacies’ Drug Enforcement Agency (DEA) licenses. This created the impetus for stakeholders from across the Los Angeles County emergency medical services (EMS) system to come together and redesign the flow of controlled drugs through the EMS provider agencies using hospital-based systems as a model. This process required a change to state regulations, and the resulting fire department-based pharmacy can serve as a model for other provider agencies to follow. The cost of the new system has been offset largely by the reduction of expired drugs and new reverse distribution contracts; the expertise of the pharmacist in navigating drug shortages and improving regulatory compliance has been invaluable.
The county of Los Angeles encompasses approximately 4,085 square miles, featuring 88 cities and 10 million residents. The Los Angeles County (CA) Fire Department (LACFD) provides 911-response EMS services for 59 of these 88 cities as well as for all unincorporated county areas, serving approximately 4.1 million residents. LACFD operates out of 174 fire stations and is an all-hazard EMS provider agency with air, sea, and land operations responding to approximately 350,000 calls annually. The Los Angeles County EMS Agency is the regulatory agency that oversees LACFD and all other emergency medical services (EMS) provider agencies operating within the county.
Prior to 2015, LACFD, like many other EMS provider agencies, obtained its controlled drugs (morphine, midazolam) from pharmacies affiliated with the three county-owned hospitals. The process was time-consuming and laborious, involving completion of multiple paper forms and many handoffs such that the drugs passed through numerous hands en route to each fire station. The drugs were obtained using the hospital pharmacies’ Drug Enforcement Agency (DEA) licenses. There was limited oversight of the restocking process by either the pharmacy staff or the LACFD EMS medical director.
In December 2015, the one of the county hospital pharmacy directors informed the EMS provider agencies that, effective July 1, 2016 (later extended by 12 months), the hospitals would no longer provide controlled drugs under the pharmacies’ DEA license. The California Board of Pharmacy (BOP) had begun holding pharmacy directors’ personal pharmacy licenses accountable for diversion of controlled drugs at their facilities. Diversion at county pharmacies could result in the shutting down of pharmacy operations, which would cripple the hospitals’ operations. The hospital pharmacy directors had little knowledge or understanding of how the drugs dispensed to EMS providers were stored, used, or accounted for once they were taken from the hospitals. Although there had not been any diversion discovered in the LACFD supply process, hospital pharmacies were no longer willing to assume responsibility for dispensing the drugs given the increased scrutiny and perceived risk to hospital operations. The pharmacy directors proposed shifting responsibility to the EMS provider agency medical directors’ DEA licenses. However, the process of procurement was so inefficient and fraught with risk that none of the physicians were willing to accept the risk to maintain the status quo. Over the ensuing 18 months, local, state, and federal stakeholders came together to design new processes for the ordering, storage, waste, and accountability of controlled drugs. The resulting process improved drug accessibility, security, and accountability throughout the region, and may serve as a model for agencies across the country.
The eventual solution to this problem was not complex. Automated drug delivery systems (ADDS) were introduced to the hospital world in the late 1980s; since then, the technology has undergone multiple evolutions. As of 2011, 89 percent of hospitals had incorporated ADDS.1 Hospitals order their pharmaceuticals to a single hub–the central pharmacy. From there, the drugs are brought to satellite areas of the hospital (spokes) where they are stored in ADDS. The ADDS communicate back to the hub and inform the pharmacists of errors, discrepancies, and the need for restock. The clinical staff working in the spokes can log into the system using biometrics, retrieve medications ordered from the hospital’s electronic medical record (EMR) system, and administer these medications to patients. The pharmacists can then remotely review all transactions, and the ADDS software is capable of alerting pharmacy staff to concerning patterns of system access. This process provides efficient access to critical drugs without impeding patient care, has inherent strong security measures, and ensures accountability for all transactions. In the hospital world, ADDS have been shown to improve operational efficiency by reduction in the costs of expired drugs, drug storage, and the reduction in clinician time on medication-related activities.2 Through decades of use, stakeholder organizations have weighed in on best practice and pitfalls related to the use of ADDS.3 The goal was to design a system for the LACFD that would operate similarly to the hospital model, with a central pharmacy hub and strategically chosen fire stations as the spokes. The system would incorporate an ADDS vault at the main pharmacy and satellite ADDS machines in the fire stations, much like the coordination of the central pharmacy and individual treatment units within the hospital (e.g., the emergency department, intensive care unit, operating room). As simple as this solution seemed, its implementation encountered several regulatory roadblocks.
Drug Enforcement Agency (DEA)
Existing DEA regulations created two significant hurdles to the creation of an ADDS hub-spoke model for drug distribution. First, the DEA’s Los Angeles field office’s initial interpretation of existing law did not permit EMS providers to operate ADDS. They advised the group that an EMS provider could use a drug safe, but the legal operation of ADDS by an EMS provider would require a waiver of the Controlled Substances Act (CSA). With their help, a waiver request was submitted to DEA headquarters in Washington, D.C., in July 2016. At the end of August 2016, the LAC-EMS received a reply that the waiver was rejected, but that the central office’s interpretation of the CSA did not prohibit the use of ADDS by EMS provider agencies.
Next, the DEA stated that if an agency distributes five percent or more of its total received controlled drugs from its hub, it would be classified as a drug distributor. This is a distinction between the hospital and prehospital environment because hospital central pharmacies are not licensed this way. The hospital central pharmacy distributes virtually all of its controlled drugs, but the spokes within the hospital are typically at the same physical address. In the LACFD, there would be satellite ADDS more than 60 miles from the central hub. Per the DEA, the proposed model would more closely resemble the licensure model of a Walgreens or CVS than a hospital system. This left two options, which follow:
- If the EMS provider agency wanted to avoid the licensure requirements of a drug distributor, it could order its controlled drugs from an outside drug distributor and have them delivered to each individual site. Each ADDS would need to be licensed by the DEA as a practice location, but the provider agency would not be required to have a DEA distributor’s license. For agencies planning to operate a small number of ADDS, this would be a viable option. For example, a department with three stations could license a single ADDS, and the units could come to the ADDS to perform the restock.
- LACFD planned to place 24 satellite ADDS. However, managing the receipt of controlled drugs from an outside drug distributor to each station would be a logistical nightmare. For larger agencies, they could receive their controlled drugs at a single ordering point: the central pharmacy. Although the DEA security and documentation requirements for a distributor are far stricter than for a registered practice location, the logistics of operating a large system are far more simple with a hub-and-spoke model that a distribution license allows.
The process of designing the ADDS system for EMS was proceeding in earnest because the hospital pharmacies were anxious to transition responsibility. As this process was progressing, the Protecting Patient Access to Critical Medications Act of 2016 (HR-4365) was introduced in Congress in January 2016.4 A reintroduced version–HR-304–passed through Congress and was signed into law by President Trump in November 2017.5 Within this bill are specific provisions stipulating that EMS agencies not be treated as distributors, and that there be no requirement for each designated location to be separately licensed. In subsequent conversations with the DEA, the LACFD was informed that it would take the DEA approximately one to two years to review the new law and update its regulations to reflect the changes. Furthermore, although the new law reduced the DEA licensure requirements, much of the regulation of controlled drugs occurs at the state level.
California Board of Pharmacy (BOP)
The first question faced by the BOP was one of jurisdiction. The BOP licenses and regulates pharmacists and pharmacy technicians, but not physicians, who are licensed and regulated by the medical board. After discussion with both boards, it was determined that, although the oversight of the EMS medical director fell under the auspices of the California Medical Board, the regulation of the controlled drugs fell under the BOP.
Per California pharmacy regulations, the only agencies permitted to operate ADDS were hospitals, skilled nursing facilities, and health care facilities. Although the regulations did not exclude EMS provider agencies or fire stations, the BOP’s stance was that California is not a permissive state, and the regulations need to give expressed authorization to an entity for it to be compliant. Unfortunately, since patient care does not occur in the fire stations, the BOP would not consider the fire stations to be health care facilities. Changing the BOP regulations would require new legislation to amend the Business and Professions Code. The BOP agreed to co-author a bill with the EMS Medical Directors’ Association of California (EMDAC), and California SB-443 (Pharmacy: emergency medical services automated drug delivery system) was drafted in January 2017.6 As the bill made its way through the legislative process, several important questions arose and were negotiated.
- California law does not allow pharmacy technicians to fill ADDS machines with controlled drugs unless under direct supervision by a pharmacist. The first draft would have only allowed a pharmacist or physician to refill machines. However, at the time, the LACFD did not employ a pharmacist, and hiring a physician or pharmacist to drive to the 24 planned ADDS spread over the county would be difficult and expensive. The LACFD employs nurses, but prior problems between the California Board of Registered Nursing (BRN) and the BOP regarding drug diversion made this idea unacceptable to the BOP. In the final version of the bill, the BOP agreed to allow a cadre of licensed paramedics to perform the refill as long as the process involved a witness at each stage.
- The BOP required each site housing an ADDS to have an individual DEA registration. Although HR-304 did not require this at the federal level, it is still the prerogative of the state to have more onerous licensing requirements.
In California, legislation that is perceived to expand the paramedic scope of practice often meets heavy resistance. However, SB-443 was met with little resistance in Sacramento and was signed into law by Governor Brown in September 2017. The easy passage of this legislation is likely because of unanimous support of the BOP and careful crafting to ensure that it did not change the paramedic scope of practice.
Although the ADDS technology in the hospital setting has evolved significantly over many years, it was never designed for use in the prehospital environment. In the hospital environment, many systems lock out providers from removing controlled drugs from the ADDS unless a valid order has been placed a physician, verified by a pharmacist, and then crossed over from the EMR and ADDS software systems. But, in the prehospital environment, the drugs are placed in a drug box in a vehicle for use in a potential future patient. Thus, at the time that drugs are removed from the ADDS, no order exists. Accessing the ADDS to restock a drug box could potentially be linked to the use in a prior patient based on a data transfer from an EMS electronic patient care record (ePCR). However, to date, major vendors have not developed this functionality. The LACFD works around this limitation by taking advantage of a back-door system in the ADDS that allows manual entry of patient information. In the hospital, this functionality is used to emergently pull medications for patients not yet in the EMR. Unfortunately, while this process allows the system to work, it circumvents a key security function of the ADDS. At the LACFD, security is maintained by requiring a witness to be logged in biometrically at every step. Furthermore, all cases of ADDS access are audited retrospectively by the LACFD Pharmaceutical Services Section. LACFD continues to work with vendors to develop data connections.
The Fire Department Pharmacist
To build a new controlled drug process that was compliant with state and federal pharmacy law, there was a clear need to bring in the expertise of a pharmacist. The LACFD was able to justify hiring a full-time pharmacist to manage the ADDS program and all pharmaceutical operations. Given the scale, it would have been impossible for the LACFD medical director to effectively manage the pharmaceuticals in addition to other duties. Even for agencies operating ADDS on a smaller scale, involving a pharmacist would be extremely valuable. EMS physicians lack structured training on the management of controlled drug operations. Understanding regulation, management, and supply chain issues surrounding a controlled drug program are covered only tangentially in the EMS core content. Oversight by the EMS medical director without the support of a pharmacist could make systems vulnerable to poor documentation, legal noncompliance, and drug diversion. These issues could expose the medical director and his provider agency to liability and licensure action.7
In addition to ensuring legal compliance, the LACFD has been able to use the expertise of the pharmacist in many other ways, some of which follow:
- Emergency medication shortages. The LACFD has maintained supplies of emergency medications by using the department’s full-time pharmacist to monitor expiration dates, apply for DEA extensions, rotate stock, adjust stocking levels, and establish relationships with new sources.
- Reducing waste. Prior to implementing the LACFD EMS Pharmaceutical Services Section, stations were free to order noncontrolled drugs based on their perceived need. This resulted in enormous quantities of drugs expiring on the shelf.The LACFD’s annual pharmaceutical budget (controlled and noncontrolled drugs) for 2016-17 was $1,050,000. Centralizing the ordering process has allowed fire stations to be resupplied based on documented usage rather than on perceived need. By moving pharmaceutical ordering from the fire stations to the central pharmacy hub, the LACFD estimates savings of nearly 60 percent, or $600,000 annually.
- Reverse distribution. Prior to launching the pharmacy, expired drugs were either wasted or donated to the local paramedic training programs. Our pharmacist recognized the value of the expired pharmaceuticals and established a reverse distribution contract that allows the department to return some of the expired drugs to the supplier for a refund credit. In the first full year, the LACFD received $28,000 in credits through reverse distribution of expired drugs.
- Treatment protocols. The pharmacist reviews new treatment protocols to ensure that they meet best practice for medication safety including appropriateness by indication, administration routes, and dosages.
Although the cost of employing full-time pharmacy staff can be a significant challenge, the cost of a noncompliant program can be severe. The LACFD has found the potential cost savings dramatic. The LACFD employs a full-time pharmacist and pharmacy technician. Labor costs for the two positions, including salary and benefits, are $260,000 annually. The projected and realized cost savings of the pharmacy program have more than covered the staffing cost.
As we have learned in the emergency department (ED), the emergency medicine pharmacist is a valued member of the clinical care team. Clinical pharmacist involvement in the ED can reduce severe medication errors and improve physician efficiency and compliance with evidence-based medical practice.8-11 There are also examples of emergency medicine pharmacists contributing to prehospital protocols.12 Some of the documented benefits of incorporating pharmacists into the ED team will not translate to the field because their role in the prehospital world will be administrative rather than clinical. However, the expertise brought by an EMS pharmacist can improve prehospital operations, and bringing on a part-time pharmacist should be within the budgetary reach of medium-sized EMS provider agencies.
ADDS machines are also expensive, but they are designed to assist with security and documentation. The LACFD was fortunate that the Los Angeles County Department of Health Services (DHS) already had a contract in place with an ADDS vendor because the compressed timeline did not allow for a Request For Proposal (RFP) process. As fellow county government departments, the LACFD was able to quickly access the contract and procure the equipment. The LACFD acquired 24 ADDS machines and a central safe on a five-year lease for $253,200 per year. The price included on-site service, software upgrades, and so on. There are several vendors that produce ADDS that can work in the prehospital environment. Many of the vendors also offer different sizes to suit the scale of the operation.
Current Restock Process
LACFD currently uses an ADDS vault at the pharmaceutical services section to supply 24 satellite ADDS machines in strategically located fire stations (Figure 1).
When a controlled drug is used on a patient, it is documented in the ePCR and vehicle log. The two-paramedic crew then drives to the nearest ADDS station. All LACFD paramedics have their biometrics within the system, so any ADDS machine can be used for restock. The paramedics use their ID to enter the ADDS room, and both paramedics are required to log in to the ADDS. The patient information is entered, along with the quantity needed for restock. Once entered, a drawer opens with the appropriate amount of medication available; no counts are required. The medication is loaded into the vehicle drug box, the logs are updated, and the restock is complete. What once took days or weeks now takes only minutes–all steps are electronically recorded, and all transactions are audited by the pharmacist (Figure 2).
The opioid crisis has brought increased scrutiny to all levels of controlled drug management and compliance. Working with regulatory bodies and system stakeholders, it is possible to develop an efficient system for controlled drug restock that allows for improvement in accessibility, security, and accountability. We also believe that our model is highly scalable, even for small- to medium-sized EMS provider agencies. Hiring a pharmacist, even part-time, can be very cost effective while improving processes and compliance.
We are hopeful that, as more departments launch similar programs, the system will continue to evolve. Four particular areas of opportunity include the following:
- Developing state pharmacy regulations specific to the needs of EMS. Although HR-304 will be very helpful at the federal level, these changes need to trickle down to the states. The California BOP was very helpful in embarking on the legislative process with us; we encourage other agencies to work with their pharmacy boards to help them understand the unique needs of the prehospital environment.
- Software enhancements should allow communication between ePCR and ADDS systems. This can streamline the restock process and improve system security by removing the ability to manually enter patients into the system.
- EMS fellows would benefit from targeted training on the management of pharmaceutical supply chains, management of drug shortages, and the legal requirements of a controlled drug program.
- Pharmacist subspecialty training in prehospital care.
The authors would like to acknowledge the Los Angeles County EMS Agency, the California Board of Pharmacy, and the EMS Medical Directors’ Association of California for their contribution and collaboration in California SB.
Declaration of Interest Statement
The authors report no conflicts of interest.
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- Chapuis C, Bedouch P, Detavernier M, Durand M, Francony G, Levagne P, Foroni L, Albaladejo P, Allenet B, Payen JF. Automated drug dispensing systems in the intensive care unit: a financial analysis. Chapuis et al. Crit Care. 2015 Sep 9;19:318. doi: 10.1186/s13054-015-1041-3.
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- H.R. 4365 – 114th Congress: Protecting Patient Access to Emergency Medications Act of 2016. www.GovTrack.us. Available at https://www.govtrack.us/congress/bills/114/hr4365. Accessed January 4, 2019.
- H.R. 304 – 115th Congress: Protecting Patient Access to Emergency Medications Act of 2017. www.GovTrack.us. Available at https://www.govtrack.us/congress/bills/115/hr304. Accessed January 3, 2019.
- SB-443 Pharmacy: Emergency Medical Services Automated Drug Delivery System. California Legislative Information. Available at http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB443. Accessed January 4, 2019.
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