In a recent ruling, the Fifth Circuit Court issued a decision limiting the DEA’s grounds for determining that a pharmacist is in violation of their responsibility to identify and report red flags when filling prescriptions. This ruling is significant and provides pharmacists with greater protection. To understand how this new ruling and updated standards could affect you or your pharmacy, talk with a healthcare liability lawyer from MehaffyWeber.
Understanding a Pharmacist’s Responsibility When Filling Prescriptions in Texas
Pharmacists are responsible for ensuring that prescription drugs are only dispensed to the prescribed recipient for legitimate medical purposes, especially where controlled substances are concerned. They have a duty to carefully review prescriptions and reject those that do not appear to be valid. According to CFR § 1306.04, this is known as a pharmacist’s “corresponding responsibility.” Pharmacists act as another layer in the checks and balances system to prevent drugs from getting into the wrong hands.
As such, pharmacists must look for red flags in prescription orders that could negate their validity. These signs are outlined in Appendix D of the Drug Enforcement Administration’s (DEA) Pharmacist’s Manual. Below is a closer look at some of these indicators.
Unusual Prescriptions
Prescriptions that are out of the ordinary for any reason might indicate that a prescription is not legitimate. While a pharmacist’s job is to dispense medications, they are also responsible for reviewing them for unusual patterns or dangerous errors.
Some of the signs of an ‘unusual prescription’ that a pharmacist may be liable for can include prescriptions for larger quantities or doses than are common in the area or for the individual. Individuals who visit frequently, come in groups with prescriptions from the same doctor, request prescriptions on behalf of another person, or request dangerous combinations can be a reason for concern.
Fraudulent Prescriptions
In addition to catching dangerous mistakes, pharmacists are also responsible for identifying fraudulent attempts to obtain prescription drugs and controlled substances. A few red flags for this may include doses or directions that are not normal, or the prescription looks too legible or has noticeable changes each time. Additionally, a prescription that is a photocopy or doesn’t follow industry-standard terminology or practices can be a reason for pharmacists to reject a prescription request.
The DEA’s Long-Standing Stance on Pharmacist Violations
Pharmacists are expected to abide by DEA rules when it comes to operations and reporting potential red flags. If they identify any instance of illegitimate prescriptions or fraudulent behavior, they are supposed to exercise their right not to fill a prescription. They must also thoroughly document and report the red flag through all applicable channels. If pharmacists or a pharmacy fails to follow these protocols, they could be subject to criminal charges by the DEA.
When it comes to these violations, the DEA has long held a stance that pharmacists should be held liable for having a reasonable suspicion that a prescription was illegitimate, as well as having actual knowledge that a prescription was invalid or fraudulent. Failure to report a red flag is seen as willful blindness. This has often been their grounds for prosecuting pharmacists, or, in the case of Neumann’s Pharmacy, LLC v Drug Enforcement Administration, the DEA revoked the pharmacy’s registration.
The Fifth Circuit’s Ruling on Red Flag Usage
With the resolution of the Neumann Pharmacy case, the Fifth Circuit Court narrowed the DEA’s scope for actionable violations to prevent wide over-reach of authority. They stated that pharmacists must have had actual knowledge that a prescription was invalid and must have failed to follow the proper reporting processes in order to be held liable. Within the Fifth Circuit, the DEA must be able to concretely provide evidence of these actions rather than simply a reasonable suspicion.
This is an important distinction because the court argues that certain conditions may not always warrant a violation even if it appears to be a red flag. How these situations are handled, though, are important, and all actions should follow regulatory guidance so that allegations of willful blindness cannot be made against the pharmacist for not doing their due diligence per their responsibility.
Implications of This Ruling on Texas Pharmacists
This ruling by the Fifth Circuit Court has several implications for Texas pharmacists. One of the primary ones is that it provides pharmacists with a greater level of protection of their rights. Because these cases now rely on actual knowledge instead of reasonable knowledge, the DEA must provide a greater body of evidence of wrongdoing before it can take action against a pharmacist. This is a very important aspect, as it makes it harder for the DEA to take action and provides pharmacists with a defense.
It is also important to note that the ruling by the Fifth Circuit Court applies to federal actions in response to violations. Pharmacies and pharmacists throughout Texas and other Fifth Circuit states must still adhere to all applicable state-level regulations that govern prescription drug handling and red flag reporting. While misconduct could still subject a pharmacist to state charges, it would not necessarily carry the additional weight of federal charges.
For the DEA to claim a federal violation, the action must also be in direct opposition to The Controlled Substances Act. This act governs how pharmacies, medical practitioners, individuals, and other parties may use drugs that are classified as controlled substances. Drugs covered by this act are often easily abused, create dependency, and pose a dangerous threat to an individual or public health, which is why pharmacist responsibility is critical and why violations are punishable under federal law.
Consult MehaffyWeber When You Need Legal Representation
If you are a pharmacist or a pharmacy facing legal repercussions for dispensing drugs for illegitimate purposes or have been approached by the DEA, MehaffyWeber can review your case and help you determine your rights. We provide counsel to help protect you and make sure you are not treated unfairly under the law. Our team monitors all rulings and changes in these matters to ensure you receive up-to-date direction and advice throughout your case. Contact our firm today to schedule a consultation.