On Jan. 9, 2004, a routine audit of morphine usage was requested by the medical director of MedStar ambulance in Fort Worth, Texas. Three days later, a 41 vial discrepancy was reported. Further investigation discovered the patient care reports and narcotic usage replacement forms were inconsistent. The next month was a roller coaster ride of conversations with the Texas Department of Health, Texas Department of Public Safety (which oversees controlled substances administration in Texas) and the U.S. Drug Enforcement Agency (DEA). The self-reporting did not make things smoother.
In one conversation, a DEA representative said, "This is strike one. There will not be a strike three." The medical director feared for his license, and the investigation produced a great deal of anxiety for EMS medical direction until the matter was resolved to the satisfaction of the DEA. But the investigation resulted in a "top down" restructuring of scheduled drug utilization that, today, makes the controlled substance management program of MedStar a model for the country.
Nothing could have surprised an EMS physician from Texas more than to be contacted by a representative of the Texas Department of State Health Services (DSHS) who was investigating a complaint filed by a citizen of a tiny town west of Austin. The DSHS representative arranged for a meeting with the EMS medical director to audit scheduled drug usage by the small volunteer EMS agency that he served in a volunteer capacity. The medical director immediately went to the EMS agency and performed his annual scheduled drug audit. What he found horrified him.
The medical director served in an "unfunded position" with the agency that provided service to a small geographic area, as many physicians do, because he felt it was the right thing to do. He had established policies and procedures for the ordering, dispersal, dispensing and monitoring of controlled substances within the agency. He personally conducted an annual audit of all scheduled drugs, including the recently added drug fentanyl.
The medical director had heard of the great results in prehospital pain control through the use of fentanyl. Encouraged by what he had seen and heard at national EMS gatherings, and reassured by his review of the EMS literature, he added the drug to the formulary of this small agency and incorporated it into his standard auditing process. Doing all of this work out of the goodness of his heart, he couldn't imagine what was about to happen to him.
In most systems, a level of trust ultimately falls to a member of upper-level management to "do the right thing at all times." However, occasionally, a trusted member of management can get away with a crime—often for a long period of time—without getting caught. Such was the case here.
Shortly after the medical director's previous annual audit, the paramedic director of this small service began to "divert" (the DEA's polite term for stealing) fentanyl, ultimately taking more than 200 ampules of this schedule II drug over about a year's time.
The medical director's latest audit caught the paramedic director red-handed. When confronted with the theft, the paramedic claimed that he had been giving the fentanyl to his spouse to treat severe headaches.
How did the paramedic director get away with stealing narcotics for so long? Frequently, if he was confronted by his EMS partner when he would take the fentanyl out of supply, he would say that the medical director had given him permission. Indeed, records revealed that the paramedic would often telephone the medical director around the time that he was taking the fentanyl out of inventory and would state to his partner that the medical director had given him permission to administer the fentanyl to his spouse. These facts were soundly refuted in subsequent testimony in the case.
Upon discovering the diversion of this astounding quantity of fentanyl, the medical director took appropriate action. He fully investigated the matter at the local level, satisfying himself that the paramedic appeared to have acted alone and in an illegal manner. He notified the Texas DSHS and worked to have the paramedic's license revoked. He also notified the DEA and reported his findings, including his plan for preventing future diversions.
He felt he had taken all appropriate steps. What he didn't know was that the roof was about to fall in. The medical director received a letter from the U.S. attorney's office, enclosing a proposed complaint in federal court to be filed against the medical director, the EMS agency and the paramedic. In Count One, the DEA claimed that DEA Form 222 (third copy) had not been completed correctly because the date and quantity of drugs had not been handwritten into the boxes indicated on the third copy of the form. The government sought to recover from the medical director and the EMS agency $25,000 for each Form 222 alleged to be in violation.
In addition, the government sought to fine the medical director and the EMS agency $10,000 for each ampule of fentanyl that was diverted by the paramedic director without completing a proper record of dispensing the medication. The total of fines sought by the government was between $2.5 million and $7 million, depending upon the method of calculation that could be adopted by the court during the trial.
To make matters even worse for the medical director, the State Health Department reported him to the Texas medical board, and action was initiated to revoke his medical license. Fortunately, under the wise guidance of EMS attorneys Jack and Chris Ayres, the case was resolved, with the medical board relieving the medical director of any responsibility and clearing his record completely. On the advice of his attorneys, the medical director paid an agreed upon amount in settlement of the claims by the government to avoid the risk of an adverse judgment and the potentially tremendous cost of attorney's fees and expenses in connection with a protracted federal litigation.
All EMS providers recognize the need to have available certain controlled substances for treatment of patients in the prehospital arena. These medications include:
- Benzodiazepines for acute convulsions;
- Benzodiazepines for excited delirium;
- Benzodiazepines for sedation of severe anxiety;
- Benzodiazepines, often used together with a narcotic, in preparation of a patient for an invasive procedure, such as endotracheal intubation, either in induction or maintenance; and
- Narcotic analgesics, such as morphine and/or fentanyl for pain management in such conditions as "acute coronary syndrome" and other severe pain including fractures.
- What is clearly evident from the experiences described above is that the DEA requires absolute accountability by an EMS agency that provides (or is considering the provision of) a controlled substance during patient care.
The areas of accountability include:
- Ordering and receipt of medications in a manner completely compliant with DEA regulations, with careful attention paid to proper completion and signature on the third copy of the DEA-222 forms;
- Distribution of medications within the agency;
- Documentation of usage and wastage;
- Resupply based upon only documented usage;
- Auditing procedures, including both routine and random inspection; and
- An investigation procedure in the event of incorrect audits.
Records must be kept by the agency in a manner consistent with the DEA requirements. The DEA has the authority to schedule inspections and audits of the controlled-substance usage by any "entity" that maintains inventory of these substances.
Controlled Substance Policy for MedStar Ambulance Service
- Each vial has unique tracking number
- Providers are assigned specific numbered narcotic pouches
- Resupply can occur only after patient care reports and narcotic usage resupply forms match
- Weekly reports are made of providers' controlled substance administrations
- Scheduled and random controlled substance audits are conducted
- Random provider drug testing is conducted
Current DEA Actions Affecting EMS Agencies
Efforts are underway in Texas and Oklahoma to obtain clearer interpretation of specific DEA regulations that may significantly affect EMS agencies. First, although the term "stored" is not specifically defined in DEA regulation, the authors have been recently made aware of an interpretation of this language that may be a difficult pill for EMS agencies to swallow. Specifically, we've been informed that controlled substances are considered "stored" if an ambulance is specifically assigned to a fire station, especially if the ambulance is parked there for any significant period of time. Moreover, this interpretation of "stored" is not only directed toward controlled substances kept in a cabinet for ambulance resupply, but also to the drug box on the ambulance located on site.
The effect of such an interpretation—should it become pervasive—will be to require individual fire stations, and possibly individual ambulances, to acquire and maintain separate and distinct DEA registrations. It's difficult to estimate the potential burden such action would present to EMS agencies across the country.
Second would be a requirement for an EMS agency that disperses controlled substances to individually DEA-registered ambulances to register their central dispersal area with the DEA as a "distributor" of controlled substances. This action will amplify the density of management expense and effort in the already over-burdened EMS sector.
It's clear that EMS medical directors and management staff must be vigilant in their oversight of implementation, administration and monitoring of controlled substances within their agencies to best serve the public and avoid running afoul of investigation and incurring significant penalties. Those potentially affected by the need for individual registrations of both emergency vehicles and central inventory systems should carefully monitor upcoming developments in the interpretation of DEA regulations.
Disclosure: The authors have no conflicts of interest with the sponsors of this supplement.