The Scope of a Pharmacist’s Legal Duty
Under the CSA, pharmacies have a legal duty to ensure they only fill prescriptions for legitimate medical purposes. A “prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.” Similarly, pharmacists may only fill prescriptions “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Although “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner... a corresponding responsibility rests with the pharmacist who fills the prescription.” Pharmacists are, thus, prohibited from filling a prescription for a controlled substance when they know or have reason to know that the prescription was not written for a legitimate, medically sound purpose.
Pharmacists have an affirmative, as opposed to a passive, obligation to investigate each prescription. Pharmacists bear the burden to establish the validity of each prescription they fill for a controlled substance. Further, pharmacists may only dispense controlled substances if they are properly registered with the DEA and in compliance with all DEA regulations. Like pharmacists, pharmacies also have a responsibility to ensure that a controlled substance prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”
Trinity Prescriptions
Pharmacists are required to monitor prescriptions for what the industry refers to as “red flags.” A red flag is a circumstance arising in the course of prescribing that may indicate a risk of patient harm or prescription drug abuse. Red flags should cause pharmacists to pause and weigh the potential patient harm before filling a prescription. A common red flag for prescription drug abuse is a prescription for cocktail medications. Cocktail medications are combinations of controlled substances that are often abused, and when taken in combination, increase the patient's risk of overdose or death. One particularly lethal type of cocktail medication is the trinity cocktail.
A trinity cocktail is a combination of an opioid, a benzodiazepine, and a muscle relaxer. Because of the strength of the three-pronged drug combination, trinity cocktails are prone to drug abuse and can be lethal, a red flag for pharmacists. Generally, a trinity cocktail prescription requires pharmacists to investigate the necessity of the prescription, resolve any potential concerns over its use, and document the prescription. There are circumstances when a trinity cocktail can be prescribed, but if a pharmacist cannot resolve the red flag, the pharmacist should refuse to fill the prescription. Because of their danger and high likelihood of abuse, pharmacies filling prescriptions for trinity cocktails have been subject to increased scrutiny in recent years by government agencies, such as the DEA.
The DEA and Registration Revocations
In addition to state licensing requirements, pharmacies dispensing controlled substances must register with the DEA. The DEA has the authority to revoke a pharmacy’s controlled substance registration. There are several bases on which the DEA may revoke a pharmacy’s controlled substance registration, including actions taken by the pharmacy that result in the registration being inconsistent with the public interest.
To determine if a pharmacy’s controlled substance registration is inconsistent with the public interest, the DEA must consider the following factors:
- maintenance of effective controls against diversion of particular controlled substances into other than legitimate medical, scientific and industrial channels;
- compliance with applicable state and local law;
- prior conviction record of applicant under Federal or State laws relating to the manufacturing, distribution or dispensing of such substances;
- past experience in the distribution of controlled substances; and
- such other factors as may be relevant to and consistent with the public’s health and safety.
Not every factor necessarily needs to be established, and the DEA has authority to give certain factors more weight than others in determining registration revocations.
To initiate a registration revocation action, the DEA serves the offending provider with a show cause order, detailing the alleged violations committed by the provider and asserting the DEA’s legal basis for revoking the provider’s registration. The provider may then respond to the show cause order, providing a defense of its actions and requesting a hearing. Registration revocation hearings are adjudicated by a federal administrative law judge (ALJ).
In a registration revocation hearing, the DEA has the burden of establishing it has proven the legal requirements to justify the revocation. The DEA generally presents a retained pharmacy expert to opine on the provider’s breach of its duty of care. The provider has the option of presenting a rebuttal expert. If the DEA has met its burden, the pharmacy can attempt to mitigate the threat it poses to the public by accepting responsibility for its actions and demonstrating it will not continue engaging in the misconduct proven by the DEA. If a pharmacy can establish that, despite the DEA’s success in proving its misconduct, the pharmacy will not continue its misconduct, the ALJ may opt not to revoke the pharmacy’s registration. Decisions made by an ALJ are subject to review by the DEA acting administrator.
In recent years, the DEA has been focused on curbing the prescription of trinity cocktails and has used registration revocations to enforce this effort. A closer look at the ALJ orders arising from these actions provides insight into the trinity cocktail problem and the DEA’s approach to combatting the issue.
DEA Trinity Prescription Enforcement Actions
Several ALJ orders revoking providers’ controlled substance registrations for trinity prescription violations have been issued in recent years. While the ALJ orders are publicly available, the orders likely only represent a small sample of the DEA investigations into trinity prescription violations because not every provider requests an ALJ hearing, so many DEA investigations and revocations are never published. The investigations that do result in hearings detail what providers should be aware of to avoid or successfully handle trinity prescription investigations and ensure the DEA has no basis to order a registration revocation.
In the matter of Trinity II, the DEA sought to revoke the controlled substance registration of a Florida-based pharmacy. The DEA alleged several instances of misconduct including, in part, filling trinity cocktail prescriptions for three separate patients. To support its allegations, the DEA submitted the prescriptions, the fill stickers, dispensing logs, and the patient profiles for the patients allegedly prescribed trinity prescriptions. While these documents established that the pharmacy did fill trinity prescriptions for three Florida patients, the documents did not establish why the prescriptions were filled. This is because the pharmacy did not provide (and appears did not maintain) any notes reflecting the pharmacists’ decision to fill these prescriptions or reflecting the pharmacists’ efforts to resolve the red flags raised by the trinity prescriptions. Because of this, the ALJ inferred the pharmacy ignored the red flags and, accordingly, the ALJ ruled the pharmacy engaged in activities rising to the level of misconduct inconsistent with the public interest. The acting administrator agreed and accepted the ALJ’s order, finding the pharmacy introduced no evidence establishing it accepted responsibility or that it would not continue engaging in similar misconduct. The pharmacy’s controlled substance registration was revoked.
The matter of David H. Betat, M.D. involved a DEA investigation and registration revocation of a California physician for alleged prescriptions issued for the benefit of five patients without any medical purpose including, in part, prescriptions for trinity cocktail combinations. The DEA served a show cause order on the physician, who objected to the DEA’s allegations and sought a hearing before an ALJ. On review, the ALJ determined that the physician had, in fact, issued trinity cocktail prescriptions to at least two of the patients without any documented medical justification or resolution of the red flags presented by the trinity cocktail. In addition to the lack of documentation of the patients’ need for the prescriptions, the ALJ also found persuasive the lack of any medical history or examination of the patients prior to ordering the trinity prescriptions. For these reasons, the ALJ found the physician’s controlled substance registration should be revoked, as the physician failed to accept responsibility or demonstrate they would not engage in the same conduct in the future. The acting administrator agreed and revoked the physician’s registration. A similar registration revocation proceeding took place in the same year, involving another California physician in the matter of Kareem Hubbard, M.D.
In George Pharmacy, Inc., a Florida-based retail pharmacy was under review by the U.S. Department of Justice (DOJ) for registration revocation. The DOJ launched an investigation into the pharmacy and noted several practices allegedly outside the scope of usual practice and contrary to the public interest. Included in these practices was the alleged repetitive filling of trinity cocktail prescriptions for two patients of the pharmacy. The DOJ issued a show cause order and, while the pharmacy refused to voluntarily turn over its controlled substance registration, the pharmacy also failed to respond to the show cause order. The DOJ submitted the case to an ALJ for hearing. The ALJ found the DOJ’s retained pharmacist-expert credible in their opinion, in relevant part, that the pharmacy filled several trinity prescriptions without recording any medical necessity for the prescriptions and without notating any resolution of the red flags presented. Because the DOJ established its case and the pharmacy failed to provide any opposition or statement accepting responsibility, the ALJ ruled the pharmacy’s registration should be revoked and the acting administrator agreed.
The DOJ revocation decisions arm providers with valuable guidance for avoiding DOJ investigations into trinity prescription abuses. First and foremost, every revocation decision reviewed involved a lack of proper documentation surrounding the trinity prescriptions. Providers must clearly document the medical justification for ordering and filling a trinity prescription. Proper record-keeping is also crucial to comply with DEA investigators should an investigation arise. Providers must document all efforts made to resolve the red flags presented by trinity prescriptions, such as a patient interview, medical history, correspondence between the pharmacy and physician, investigation into the possibility that the prescription may be abused or diverted to persons other than the patient, and any efforts to provide alternative medications to the patient that do not pose the risk of a trinity prescription.
Pharmacies may benefit from implementing what are known as “hard stops” in their operations. A hard stop is an alert that displays on a pharmacy’s computers whenever certain prescriptions are ordered that may pose a risk to the client. Hard stops often prevent the pharmacist from completing the fill order entirely, but a similar “nearly hard stop” system can impose a stop on the fill order unless the pharmacist performs some action to resolve the hard stop. Implementing a hard stop or nearly hard stop alert system for trinity prescriptions can halt pharmacists from filling trinity prescriptions unless the pharmacist performs some additional action, such as resolving the trinity red flag and appropriately recording the resolution.
The DOJ revocation decisions also provide insights to aid providers when a DOJ investigation into trinity prescribing is already underway. After the DOJ has commenced an investigation, cooperation and providing all documentation available is crucial, as the absence of records is frequently implicated by ALJs in determinations to revoke registrations. Further, providers should make sure to respond to DOJ subpoenas and show cause orders. Failing to respond to DOJ requests and orders can result in an adverse inference against the provider at the revocation hearing. Providers should also retain an independent pharmacy expert at the revocation hearing to rebut the DOJ’s expert if possible. Finally, even if the provider disputes the DOJ’s allegations, the provider should prepare a detailed filing with the DOJ and the ALJ establishing the provider’s acceptance of responsibility over any discrepancies or alleged wrongdoing and a commitment to present no harm to the public in the future.
Conclusion
As the DOJ continues its efforts to clamp down on trinity cocktail prescribing, providers must do everything in their power to ensure compliance with the acceptable scope of practice and due diligence standards surrounding ordering and filling “red flag” prescriptions. The DOJ’s focus and the threat of registration revocation may be intimidating, but providers can learn from the growing body of law arising from prior trinity cocktail prescription revocation rulings to stay clear from DOJ scrutiny.
