As a pharmacist, facing a board of pharmacy investigation can have a multitude of adverse consequences. While losing your license might seem like the greatest risk, this isn’t necessarily the case. Increasingly, boards of pharmacy are working with pharmacy benefit managers (PBMs), state attorneys general, and the Drug Enforcement Administration (DEA) to conduct wide-ranging investigations; and, as a result, in addition to facing professional discipline, pharmacists can face both civil and criminal liability.

With this in mind, when facing the board of pharmacy investigations, pharmacists need to take a proactive and comprehensive approach to their defense. Targeted pharmacists must quickly identify the allegations against them, and then they must use the facts at hand to defend themselves by all means available. Pharmacists that are facing board scrutiny must also consider the very real possibility that they may be facing scrutiny from other entities, and they must ensure that the defenses they present to the board do not create exposure in other areas.

“Defending against a pharmacy board investigation is becoming an increasingly difficult—and increasingly risky—task. Targeted pharmacists need to work with experienced defense counsel who can help limit the scope of their investigations, evaluate all possible defense strategies, and help protect their careers to the greatest extent possible.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

So, what does it take to survive a board of pharmacy investigation? Here are 12 keys to executing an effective defense:

1. Determine the Investigation’s Trigger

A critical early step in the process of defending against a board of pharmacy investigation is to determine the investigation’s trigger. There are several possibilities, and different triggers can signal that different allegations are at issue. For example, if the pharmacy board is acting on information supplied by the DEA, this likely indicates that the investigation pertains to controlled substances or medication and drug-related issues as opposed to billing issues or patient allegations of malpractice.

With that said, the board of pharmacy investigations can—and often do—target a wide range of violations. As a result, it is critical not to make any assumptions at this stage.

2. Determine if the Board of Pharmacy is the Only Entity Investigating

In addition to determining the investigation’s trigger, it is also critical to determine whether the board of pharmacy is the only entity investigating. If you are also facing scrutiny from the DEA, another federal agency, your PBM, or a private insurer, this can significantly alter the dynamics of your situation. As noted above, pharmacy boards are increasingly working in collaboration with these other entities, and targeted pharmacists are increasingly facing civil liability and criminal prosecution in addition to professional disciplinary action.

3. Engage Defense Counsel to Intervene

Once you learn that you are under scrutiny, you should engage a pharmacy investigation lawyer immediately. Your lawyer will be able to take the preliminary steps we just discussed, and will be able to help you chart your steps while the investigation is pending. Due to the unique factual and legal issues involved in pharmacy-related matters, you must choose a lawyer who has specific experience representing pharmacists in your situation.

4. Identify the Allegations At Issue in the Investigation

Your pharmacy investigation attorney will also be able to identify the specific allegations that are at issue. There are numerous possibilities, and different issues present different risks and require different defenses. Some examples of common issues in the board of pharmacy investigations include:

• Prescription Drug Ordering and Verification Issues (DSCSA Violations)
• Drug Inventory Discrepancies
• Electronic Prescription and Recordkeeping Violations
• Patient and Prescription Verification Issues
• Staffing Issues (i.e. Inadequate Staffing Ratios and Hiring Unlicensed Personnel)
• Inadequate Supervision
• Aiding and Abetting Unlicensed Practice
• Failure to Confirm Medical Necessity
• Inadequate Physical or Digital Security
• Patient Privacy Violations (HIPAA Violations)
• Patient, Prescriber, and Payor Complaints
• Failure to Disclose Required Information to the Board of Pharmacy

To identify the allegations you need to defend against, your pharmacy investigation attorney should intervene in the investigation and communicate with the pharmacy board (and any other investigating entities) directly, and should also work with you to conduct an internal compliance assessment. This assessment, which will be protected under the attorney-client privilege, should be designed to uncover any issues that have the potential to trigger allegations. By analyzing the information gathered during this assessment in light of the circumstances of the investigation, your attorney should be able to determine both: (i) what laws, rules, or regulations you are alleged to have violated; and, (ii) what defenses you have available.

5. Be Prepared to Affirmatively Demonstrate Compliance

In many cases, affirmatively demonstrating compliance can be an effective and efficient defense strategy during a pharmacy board investigation. If your internal compliance assessment reveals that the investigation is misguided, then using the compliance documentation you have on hand to prove it could bring a swift end to the inquiry.

But, when relying on your compliance documentation during a board of pharmacy investigation, you need to be certain that the documentation is adequate. If there are deficiencies in your pharmacy’s compliance program, or if your pharmacy’s inventory, billing, and patient records do not adequately confirm compliance, then attempting to rely on these records could do more harm than good.

6. Be Prepared to Challenge Misguided Allegations and Faulty Assumptions

Oftentimes, pharmacy boards do not have the complete and full story when they initiate an investigation. They can only act on the information and documents they have, and frequently this information is incomplete—if not inaccurate or misleading.

Given that this is the case, targeted pharmacists need to be prepared to challenge misguided allegations and faulty assumptions as part of their pharmacy board investigation defense. Pharmacists must not assume that the board’s allegations are valid or that the board’s information will dictate the outcome of the investigation. Instead, they must make informed decisions based on the advice of counsel, and they must be able to rely on their counsel to present a fair and accurate recitation of the facts at hand.

7. Proactively Address Any Identified Violations

If you are aware of any violations, or if you learn of any violations within your pharmacy’s operations when conducting a privileged internal compliance audit, you will need to address these violations proactively. But, what this means will depend on the specific issues and circumstances involved.

For example, if a member of your pharmacy's billing team was incorrectly billing Medicaid even though you had comprehensive billing policies and procedures in place, then acknowledging the issue and working with the pharmacy board to reach an amicable resolution might be the best approach. On the other hand, if you were knowingly dispensing opioids to patients without valid prescriptions, this is a different matter entirely. In this scenario, proactively addressing the violation might mean ceasing the prohibited practice and formulating a defense strategy focused on preventing the pharmacy board (and potentially the U.S. Department of Justice (DOJ)) from meeting its burden of proof.

8. Implement or Establish Internal Investigation Response Procedures

During the board of pharmacy investigations, targeted pharmacists need to ensure that they (and their counsel) maintain control over all information and records in their possession. To do this, pharmacists should implement or establish internal investigation response procedures. This includes (but is not limited to) procedures regarding record collection and disclosure as well as internal and external communications.

9. Be Concise and Do Not Speculate

When communicating with pharmacy board investigators, it is important to be concise and avoid speculation. Sharing more information than is necessary can be risky, and speculating as to what a drug supplier or pharmacy technician may have done (or why) isn’t beneficial for anyone. Instead, targeted pharmacists should focus on specifically answering the questions asked (assuming it is in their best interests to answer), and they should not hesitate to say, “I don’t know,” when this is the true answer.

10. Identify and Target a Specific Favorable Resolution

Part of executing an effective defense strategy during a board of pharmacy investigation is having a specific goal in mind. An experienced pharmacy investigation lawyer will be able to assist with evaluating your options, prioritizing these options, and then developing and executing a strategy focused on achieving a specific favorable result.

11. Be Prepared for Circumstances to Change

While it is critical to have a strategy in place, it is equally important for pharmacists targeted in the board of pharmacy investigations to be prepared for circumstances to change. As new facts come to light and additional entities get involved, the dynamics of the investigation could shift drastically. Acknowledging that this is a possibility and having contingency plans in place will help ensure that unexpected events do not derail your defense entirely.

12. Identify and Preserve Issues for Appeal

Finally, as the outcome of a board of pharmacy investigation is inherently unpredictable, targeted pharmacists and their defense lawyers should identify and preserve issues for appeal throughout the process. If the circumstances are such that it is not possible to terminate the investigation without consequences or negotiate a favorable outcome, then filing an appeal could prove critical for protecting your pharmacy license and your career.