The Federal Drug Administration (FDA), Federal Trade Commission (FTC), State Board of Pharmacy (BOP), and State Department of Health (DOH) all regulate the prescription drug industry, drug manufacturers, and pharmacies to protect patients. Pharmacy benefit managers (PBMs) also significantly influence and collaborate with BOPs to ensure medication compliance.
In turn, pharmacy professionals in Florida work tirelessly to serve their patients with medications while complying with this complex web of laws and regulations. However, even the most diligent pharmacist or pharmacy owner can find themselves facing a board inquiry or investigation. Often prompted by complaints or audits, these investigations can be daunting for pharmacies. Preparation is key to protecting your career and livelihood. Here’s how to prepare for a pharmacy board investigation and safeguard your professional future against disciplinary action.
Understanding the Scope of Pharmacy Board Investigations
Pharmacy investigations typically arise from complaints filed with the Florida BOP or DOH. These complaints can come from doctors, patients, or even the Pharmacy Board itself after routine inspections or audits.
Common issues the Pharmacy Board might investigate include:
- Prescription drug errors
- Allegations of unprofessional conduct
- Lack of compliance with controlled substance regulations
- Recordkeeping and inventory discrepancies
- Violations of state and federal pharmacy laws
- Dispensing medications to patients, doctors, or others without a valid prescription
- Improper storage or handling of controlled substances
- Suspected prescription drug diversion or medication abuse by a pharmacist or staff
- Practicing pharmacy with a lapsed license
What to Do if You Receive a Board of Pharmacy Complaint
Time is of the essence. An investigation does not automatically mean guilt, but it should be taken very seriously. The outcome of an investigation can range from dismissal to disciplinary action like fines, license suspension, or even license revocation, preventing you from future work as a pharmacist or pharmacy technician.
Responding effectively can set the tone for the rest of the investigation:
- Don’t Panic. Take a moment to process the situation and review the details of the complaint.
- Stay Organized. Gather all relevant documents and information.
- Seek Guidance. Contact an experienced pharmacy license defense attorney to ensure your response is thorough and appropriate.
If you’re facing a pharmacy board investigation, reach out to Lauren A. Leikam, PLLC, right away for personalized support and a free consultation.
How to Prepare for a Pharmacy Board Investigation
1. Understand the Complaint: The Letter of Investigation
The first step is to review the complaint thoroughly. The pharmacy board will notify you in writing about the investigation, outlining the nature of the complaint. This notification will also include deadlines for responding or providing requested documents.
Keep a level head while reviewing the details. Misunderstanding the complaint or reacting emotionally can lead to unintentional mistakes. Evaluate the information calmly and objectively.
2. How to Respond
Should you respond right away? Sometimes an initial response makes sense if it’s simple background information vs. a statement about the investigation. You do have the option of waiting for the investigative file.
Any response should:
- Address the specific allegations in the complaint.
- Include any requested documents, such as prescription logs, inventory records, or standard operating procedures.
- Avoid unnecessary commentary or admissions (this information could be misinterpreted).
Every word matters in your response—seeking legal guidance from a healthcare licensing attorney like Lauren A. Leikam is critical.
3. Gather Relevant Documentation
Documentation is often the backbone of your defense in a pharmacy board investigation. Specialty pharmacies face unique regulatory challenges, making tailored documentation crucial for their compliance and legal representation.
Assemble all relevant records, including:
- Controlled substance inventory logs
- Patient communication logs (if applicable)
- Policies and procedures manuals
- Staff training records for medications and other protocols
Ensure your records are organized and easily accessible. Sloppy or incomplete documentation can inadvertently suggest non-compliance, even if no wrongdoing occurred.
4. The Investigative File: Your Timely Response
If the Florida BOP doesn’t dismiss the complaint, they’ll provide more detail on the evidence they found during the investigation. This is a second opportunity for pharmacists to submit a formal rebuttal. Now that you know what evidence the BOP is using, you can be more precise in the information you use to defend on behalf of yourself.
With experienced pharmacist license defense attorney Lauren A. Leikam on your side, a case can be made legally for why the DOH shouldn’t file an administrative complaint against your license.
5. The Probable Cause Panel: Aiming for a Dismissal
Lauren A. Leikam, PLLC, can provide invaluable support in trying to get the complaint against you dismissed. With her background as a former FL DOH prosecuting attorney, you’ll have an experienced advocate who comprehends the process, the rules, and the defense strategy. While Probable Cause Panels are private meetings conducted independently by the agency and relevant authorities, Lauren can provide legal guidance.
6. The Administrative Complaint and Potential Disciplinary Action
In some cases, the Probable Cause Panel will simply not dismiss the Administrative Complaint, and the complaint becomes a public record posted to the DOH website that anyone can access.
This medical investigation process can lead to severe consequences for your license and professional reputation. It is essential for licensed pharmacists and pharmacy owners to get help from Lauren A. Leikam as early as possible so she can help you navigate the complaint with strategy in mind.
Avoiding Common Mistakes Pharmacists Make During an Investigation
Even well-meaning physicians and pharmacy professionals can make critical errors during an investigation. Here’s what to avoid:
- Speaking Without Preparation: You may be asked to provide a statement or attend an interview. It’s best to consult with Lauren first before making statements or going to an interview. Statements in writing are best so information does not get misconstrued, but getting legal advice first is recommended.
- Ignoring the Investigation: Ignoring or delaying action on a pharmacy board investigation will not make it go away. Failure to comply with deadlines can lead to additional penalties, including an automatic finding against you.
- Assuming You Don’t Need Help: Even if the allegations seem minor, navigating the complexities of pharmacy law and regulatory processes can be overwhelming or nuanced. Seeking experienced guidance can help you avoid any risk of costly missteps.
What Can Pharmacists Do to Avoid Pharmacy Investigations and Administrative Complaints?
Pharmacists at corporate pharmacies and pharmacy owners of specialty and independent pharmacies should take particular care to align with Florida laws and regulations.
Set and Follow Compliant Standard Operating Procedures (SOPs)
Your pharmacy’s best business practices should align with Florida laws and regulations. Ensure that all pharmacy technicians and staff members are trained on these procedures and that training is documented. Consistently following SOPs can help protect pharmacies from allegations of misconduct or negligence.
Keep Up with Continuing Education Requirements
Pharmacists and pharmacy technicians are required to complete continuing education (CE) credits as part of their license renewal compliance. Make sure all CE requirements of the Florida BOP are met—and documented—to avoid administrative penalties during an investigation.
Protect Your Pharmacy License During a Pharmacy Investigation—Call Lauren A. Leikam, PLLC, Today
While no one wants to face a pharmacy board investigation, preparation is your best defense. By understanding the process, maintaining meticulous records, and seeking legal guidance when needed, you can increase your odds of protecting your career and reputation.
Lauren A. Leikam, PLLC, is here to help pharmacists navigate these challenges with clarity and confidence. With a focus on pharmacy investigations, the goal is to provide you with the tools and knowledge to move forward successfully.
Her approach is client-centered. She will work with you to develop a strategy tailored to your specific situation and ensure you feel informed and empowered. While no one can guarantee outcomes, preparation and legal advice can make a significant difference.
Take control of your future today. A well-prepared response can make all the difference in the outcome for pharmacists during a pharmacy board investigation.
