An emergency medical services (EMS) agency medical director usually focuses primarily on the oversight of the care provided directly to patients and their families. One of the medical director’s other main concerns is that of the health and safety of the EMS providers. These concerns overlap in a number of ways. This chapter specifically deals with diversion issues and identifying and managing potentially impaired providers. The more an EMS physician knows about diversion of narcotics and other substances, the more likely they are to be able to properly oversee the EMS agency–controlled substance program and to help safeguard the health and safety of patients and EMS providers alike.
Describe the components of an EMS agency narcotics control program.
Describe the process by which EMS agencies obtain, stock, and utilize controlled substances.
Discuss DEA regulations and the differences between using a personal DEA registration versus an agency DEA registration.
Discuss state narcotics laws and regulations that affect EMS agencies.
Describe proper storage and handling of controlled substances.
Discuss wasting and accountability for controlled substances.
Discuss diversion of controlled substances by providers, how surveillance may prevent and/or identify a problem, and what to do when a diversion issue has been identified.
Discuss risk factors and warning signals associated with a provider who is impaired by drugs and/or alcohol use/abuse.
Diversion means different things to different people. In its strictest sense, diversion means to move attention away from themselves through finger pointing, nit picking, manipulation, sleight of hand, or misdirection. For law enforcement purposes, diversion means the misappropriation of DEA scheduled medications from approved and/or legitimate patient usage, through doctor shopping, prescription forgery, theft, or substitution. Those who divert drugs often utilize skills mentioned in the above definition. EMS providers are not immune to diversion and agencies and medical directors need to be vigilant to ensure that such is not occurring in their systems. Drug addiction is an occupational hazard among EMS professionals, who have easy access to controlled substances such as Fentanyl, Morphine, Demerol, Versed, and other highly addicted drugs. Tampering is the diversion of medications done in such a way that it looks like drugs were never stolen. The tampered medication is then left in the system, to be used by an unsuspecting health care professional. EMS provider reports of patients not experiencing pain relief after the administration of pain medication may be a red flag indicating drug tampering.
Structured programs should be in place to account for and stocking, use, and restocking of controlled medications. EMS professionals cannot consistently divert drugs if the system has adequate physical security and an effective record-keeping system with a comprehensive audit trail. Most EMS health care professionals are unaware of the magnitude of the legal hazard associated with failing to provide adequate security and maintaining complete and accurate controlled substance records. EMS agencies should have a narcotics control program and written policies covering the acquisition, storage, and use of controlled substances. Elements of this program should include ordering and stocking of drugs, controlled access storage, crew shift counts and checklists, quality improvement programs that monitor use of drugs on specific patients, and medical director sign off on drug counts. Box 8-1 further describes elements that should be incorporated into an agency-controlled substance program. Box 8-1 Elements of an Agency-Controlled Substance Program
Each vial has unique tracking number.
Providers assigned specific numbered narcotic pouches.
Providers required to fill out narcotic resupply forms when using narcotics.
Resupply occurs only after patient care reports and narcotic resupply forms match.
Weekly reports are made of providers’ controlled substance administrations.
Medical director sign off at least weekly on reports.
Scheduled and random controlled substance audits are conducted.
Random provider drug testing conducted as well as ability to conduct testing “for cause” if concerns arise.
Agencies should also have wellness programs, which are a systematic approach for professionals to get assistance in overcoming alcohol or drug addiction. When identified, these individuals enter into a contract where they maintain sobriety to maintain their employment. Model systems use medical models and inpatient services (when needed) for the initial stages followed by regular counseling and continual drug and alcohol screening.
The Federal Drug Enforcement Agency (DEA) regulations cover narcotic dispensing and use. All physicians prescribing narcotics are required to maintain a separate license for dispensing narcotics that must be periodically renewed. Historically, many medical directors have used their own DEA license, either directly or through hospital pharmacies, to order controlled substances for their EMS agencies. Presently, this practice is discouraged and has all but disappeared in some areas due to lack of accountability, diversion issues, and increased DEA scrutiny. Obtaining separate physician DEA licenses for each EMS agency for which a physician is providing medical direction is being recommended and even required in some states. The DEA requires absolute accountability by an EMS agency that uses controlled substances during patient care. Areas of accountability are specified clearly in DEA regulations (Box 8-2).1 Box 8-2 DEA-Required Areas of Drug Accountability
Ordering and receipt of medications in a manner compliant with DEA regulations
Proper completion and signature on the third copy of the DEA-222 forms
Controlled, proper distribution of medications within the agency
Documentation of all usage and wastage
Resupply based only on documented usage
Auditing procedures that use both routine and random inspections
Investigative procedures in place in the event of incorrect audits
The EMS agency must keep records compliant with all DEA requirements. The DEA has the authority to schedule inspections and audits at any time of controlled substance usage by any “entity” that maintains inventory of these substances, including EMS. EMS agencies should educate all employees that each has a responsibility to report drug diversion according to the Code of Federal Regulations, Section 1301.91. The DEA’s stance is an employee who has knowledge of drug diversion by a fellow employee is obligated to report such information to a responsible official of the agency. The agency should treat this information as confidential and take all reasonable steps to protect the confidentiality of the information and identity of the employee furnishing it. The DEA considers failure by an employee to report diversion to directly impact the ability of continuing to allow that employee to work in a drug secured area. Furthermore, the DEA believes employers have a responsibility to inform their employees accordingly of the requirements of the code. All agencies should ensure the above has occurred. Individuals found tampering with or diverting narcotics is charged under the Federal Anti-tampering Act which carries maximum penalties of $25,000 and 10 years in prison. If a death results from these actions the maximum penalty is $100,000 and life imprisonment.
Many of the narcotics, depressants, and stimulants manufactured for legitimate medical use are subject to abuse and have, therefore, been brought under legal control. Under federal law, all businesses that import, export, manufacture, or distribute controlled substances; all health professionals licensed to dispense, administer, or prescribe them; and all pharmacies authorized to fill prescriptions must register with the DEA. Registrants must comply with regulatory requirements relating to drug security and record keeping. The DEA is also obligated under international treaties to monitor the movement of controlled substances across US borders and to issue import and export permits for such.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs (21 CFR). Individuals having knowledge of drug diversion are obliged to report such knowledge to law enforcement and the DEA through 21 CFR. Specific items that must be reported to the DEA as specified in 21 CFR are noted in Box 8-3. The Office of Diversion Control is the component of the DEA which investigates and ensures that the regulations are followed. Diversion investigations can involve physicians who sell prescriptions to drug dealers or abusers; pharmacists who falsify records and sell drugs; employees who steal from inventory or falsify records to cover illicit diversion; prescription forgers; and individuals who commit armed robbery of pharmacies. The DEA considers the theft of controlled substances from a registrant to be a criminal act, and a source of controlled substances diversion requiring notification of DEA (FR Doc 03-17127). The DEA registrant is required to notify the area DEA field office immediately upon discovery of any theft of controlled substances. If the circumstances are known, online DEA form 106 should be filed. When an investigation is needed to determine circumstances, initial notice to the DEA may be done by faxed statement and form 106 submitted after the investigation is completed. Local law enforcement should also be notified, and this may be mandatory in some states. If the medical director is the DEA registrant, this responsibility falls to them. However, if the DEA license belongs to the EMS agency it becomes their responsibility to ensure that law enforcement is properly notified and DEA forms filed. Box 8-3 Reports Required by 21 CFR*
Destruction of controlled substances
Import/export declarations (chemical reports)
Import/export permit applications and declarations (controlled substances)
Quota applications and year-end reports
Theft or loss of controlled substances
*These reports are available online from the DEA.
All states have EMS and pharmacy regulations governing the dispensing of narcotic and controlled substances. Compliance with these is overseen by state departments of EMS and pharmacy boards. Pharmacy boards license pharmacists, pharmacies and oversee the distribution of drugs within the state. There are also national organizations dedicated to drug monitoring. The National Association of State Controlled Substance Authorities (www.nascsa.org) is a 501(C)3 nonprofit educational organization whose primary purpose is to provide a mechanism through which state and federal agencies and others can work to increase effectiveness and efficiency of state and national efforts to prevent and control drug diversion and abuse. NASCSA works cooperatively with the DEA, US Food and Drug Administration, Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, National Alliance for Model State Drug Laws, state professional licensing boards, pharmaceutical companies, and other national associations. NASCA also sponsors another organization, Alliance of States With Prescription Monitoring Programs (http://www.nascsa.org/rxMonitoring.htm), to facilitate exchange of information across states with prescription monitoring programs. Both the state pharmacy and EMS agencies will conduct monitoring programs for compliance with regulations. These often include periodic on-site inspections of drug storage and records.
State regulations contain explicit instructions as to agency responsibilities in monitoring and dispensing of controlled substances as well as actions to take when loss or diversion is suspected. Failure to comply may lead to loss of licensure or certification of the pharmacy or agency involved. Medical directors should be knowledgeable of the regulations governing controlled substance storage and usage in their states. Administration of drugs by EMS personnel is limited to their scope of practice, as determined by the state office of EMS, the individual’s certification level, and the protocols established by the medical director. State regulations also allow drug administration when the EMS provider is acting within their certification level under a direct prescriber’s orders received over an active communication link (ie, online medical command).
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