Last Updated on: 17th October 2023, 10:57 pm

Preparing for a DEA or State Board of Pharmacy Investigation: What Pharmacists Need to Know

Being investigated by the DEA or your State Board of Pharmacy can be an intimidating and stressful experience. However, there are steps you can take to prepare yourself and protect your license. This article provides an overview of what to expect during an investigation, how to respond, and key strategies for your defense.

Reasons for Investigation

There are many reasons the DEA or Board may open an investigation into a pharmacist’s practice. Some common triggers include:

• Prescription drug diversion identified through PDMP data
• Suspicious prescribing patterns like high volumes of controls
• Patient or caregiver complaints
• Tips from law enforcement
• Irregularities with inventory or record keeping

Even if you believe you have acted properly, do not ignore an investigation notice. Responding promptly and asking for guidance from your legal counsel or professional association is important.

The Investigation Process

Investigations typically follow these general steps:

1. You will receive a notification letter from the DEA or Board indicating a pending investigation.
2. Inspectors will request documents like prescription records, inventory logs, policies and procedures, etc. You may also receive interrogatories or questions requiring written responses.
3. Inspectors may visit your pharmacy to interview you and employees, observe workflows, and collect additional evidence.
4. You will have the opportunity to respond to allegations and provide additional context.
5. The DEA or Board will make a determination regarding any violations and potential disciplinary action.

Responding to Document Requests

Once you receive notice of an investigation, you will likely get requests for certain documents and records. Here are some tips for properly responding:

• Do not alter, withhold, or destroy any requested documents – this can lead to additional charges of obstruction.
• Be thorough and timely in producing exactly what is requested.
• If needed, ask for reasonable extensions or clarification on vague requests.
• Provide documents in organized formats and include an index.
• Keep copies of everything you provide.

Written Interrogatories

Investigators may also send interrogatories, which are written questions you must answer thoroughly and accurately in writing. Some tips include:

• Carefully review each question and seek clarification if anything is unclear.
• Provide complete but concise responses sticking to the facts.
• Cite policies, procedures, or laws that support your actions.
• Avoid speculation or subjective statements.
• Take time to carefully review responses before submitting.

In-Person Interviews

Expect investigators to visit your pharmacy in-person to interview you and staff, inspect facilities, and collect evidence. To prepare:

• Inform employees of the process and their rights.
• Never lie or obstruct investigators.
• Request to have your lawyer present for employee interviews.
• Have policies, training records, inventories, etc. readily available.
• Document all interactions, statements made, items reviewed, etc.

Your Defense Strategy

Building an effective defense requires understanding the specific allegations and claims against you. Some key strategies include:

• Justify your actions – Cite laws, policies, professional standards, or patient needs that warranted your decisions.
• Correct misunderstandings – Provide additional context to refute assumptions or incorrect conclusions.
• Highlight diligence – Emphasize steps taken to ensure appropriate care like patient evaluations, PDMP checks, CEs, etc.
• Note gaps in policies – If current policies were inadequate, highlight the need for enhanced procedures.
• Accept responsibility – If clear mistakes were made, acknowledge them and outline corrections implemented.

Avoid speculating on events or making subjective claims you cannot substantiate. Focus on concrete facts and data that support your response.

Using Legal Counsel

Navigating an investigation is complex, so consulting an experienced attorney is highly recommended. They can:

• Ensure you understand your rights and responsibilities.
• Guide interactions with investigators.
• Identify weaknesses in the allegations.
• Help craft your defense strategy.
• Represent you in hearings if charges are filed.

Your state pharmacist association may also have resources to help advise and defend members.

Potential Outcomes

There are many possible outcomes following an investigation:

• Case closed – No evidence of violations found.
• Warning/Reprimand – Written notice of objectionable conduct.
• Fines – Financial penalties may be assessed.
• Probation – Increased oversight of practice with conditions.
• License/Registration Suspension – Temporary loss of ability to practice.
• License/Registration Revocation – Permanent loss of license.
• Criminal charges – Egregious cases may warrant criminal prosecution.

Outcomes depend on the nature of the violations, evidence of misconduct, and impact of your actions. However, taking the investigation seriously and mounting an effective response can help resolve issues and enable you to continue practicing.