Enhanced and Expanded Oversight by State Boards of Pharmacy 

Recently, BOPs have increased and enhanced their scrutiny and oversight of pharmacies and pharmacists due to heightened concerns arising from various issues throughout the country including the opioid epidemic, telemedicine, questionable marketing practices and other concerns regarding patient safety. As part of this increased scrutiny, BOPs have begun collaborating with other state investigative agencies to engage in more in-depth investigations into prescription sourcing, marketing arrangements and practices, pharmacy management agreements, and copay collection practices. Such investigations will often include the use of subpoenas and other invasive records requests. Given this challenging and evolving legal landscape, it is important to ensure that if a pharmacy, pharmacist, or pharmacy technician is being investigated by a BOP (or any other agency), that competent legal counsel is retained to navigate the investigation prudently. There are also numerous proactive measures that a pharmacy or pharmacist can undertake to ensure that more routine inspections and interactions with BOPs do not result in issues that lead to more serious disciplinary actions.  

The Relationship Between State Boards of Pharmacy and Pharmacy Benefit Managers

Another factor that has increased the importance of relationships with BOPs is the overwhelming influence that PBMs have in the pharmacy marketplace. Over the past several years there has been a pronounced increase in collaboration between PBMs and BOPs. Frier Levitt has also observed an increase in BOP investigations mirroring PBM audits and investigations, which further reflects the increased collaboration between these powerful entities. It is also well established that Disciplinary Action by one BOP can lead to disciplinary action by BOPs in other jurisdictions. Further, Disciplinary Action by even one BOP can lead to PBMs attempting to terminate a Pharmacy’s entire contractual relationship between the PBM and the pharmacy. A pharmacy or pharmacist’s dealings and interactions with BOPs cannot be taken lightly or handled haphazardly—they must be taken seriously and always handled cautiously.  

What Types of Matters Do State Boards of Pharmacy Investigate?

Matters investigated by BOPs range in complexity from straightforward administrative issues to far more serious issues including patient safety, dispensing practices, and allegations of fraud. Examples of some of the matters investigated by BOPs include:

• Pharmacy’s Overall Dispensing Practices
• Pharmacy’s Staffing Ratios and Minimum Staffing Requirements
• Drug Inventory Discrepancies and Inventory Shortfalls
• Pharmacy’s Prescription Transfer Policies, Practices and Procedures
• Failure to Provide BOPs with Notice of Changes:
  • Location, Ownership, Pharmacist-in-Charge (PIC), etc. 
• Failure to Provide BOP with Notice of Disciplinary Action in other Jurisdictions
• Practice of Pharmacy by Unlicensed Individuals or Unqualified Individuals
• Pharmacy Minimum Hours of Operation and “Failure to Operate”
• Pharmacy Supervision of Pharmacy Personnel
• Pharmacy Business Practices including Marketing Practices, Arrangements, and Agreements
• Pharmacy Inventory Maintenance, Storage Practices, and Security Policies
• HIPAA Breaches
• Patient Complaints
• Prescriber Complaints
• Recordkeeping Requirements and Storage/Maintenance of Prescription Records
• Pharmacy Policies and Procedures including handling of Controlled Dangerous Substances
• Pharmacy Policies and Procedures related to Mailing or Mail-Order Pharmacy, Delivery Services, and Shipping

How Frier Levitt Can Help

Frier Levitt attorneys have handled numerous BOP investigations, BOP enforcement actions, and other related BOP matters in many jurisdictions throughout the country. Frier Levitt has a multi-disciplinary team of attorneys including pharmacist-attorneys, experienced litigators with extensive trial experience, criminal defense attorneys, and attorneys with vast experience dealing with PBMs, all of whom are prepared to represent and defend pharmacies and pharmacists throughout all aspects of a BOP investigation, including, if necessary, at hearings or trials. The goal of defending any BOP investigation is to ensure that the rights and interests of the pharmacy or pharmacist are defended throughout the entirety of any such proceeding and that every effort is made to achieve the best result possible given the unique circumstances of the case. Where Disciplinary Action is involved or occurs, we work closely with the pharmacy and/or pharmacist(s) to ensure compliance with all applicable rules and regulations for BOPs and PBMs to avoid further issues. For more information, contact Frier Levitt today and speak with an attorney.