Developing Relationships With State Boards of Pharmacy Is Valuable for Pharmacies and Pharmacists

A pharmacy’s relationship with its state board(s) of pharmacy (BOPs) is a critical part of its ability to do business in the state(s) in which it operates. However, a pharmacy’s relationship with BOPs is also an aspect of the practice of pharmacy that may be overlooked given the demands on pharmacists and pharmacy owners. The complexity of operating a pharmacy in compliance with applicable federal law, state law, and the many contracts involved further increases the burdens on pharmacists and pharmacy owners.

The tendency to overlook these obligations may occur for several reasons, including the demands that come with owning and operating a pharmacy and the demands of dealing with numerous private, non-government third parties that are critical to operating a pharmacy, whether that be payors (eg, pharmacy benefit managers [PBMs]) or wholesalers. As a note, references to pharmacies or pharmacy in this article are intended to refer to all licensees regulated by a state board of pharmacy. Although there are variations from state to state, this typically includes at least pharmacies, pharmacists, and pharmacy technicians.

Since a pharmacy’s relationship with its BOP is crucial to the pharmacy’s overall success and long-term viability, pharmacies must develop a strategy for working with its BOP and prioritize this relationship, much like it would with its payers, prescribers, and patients. By developing a plan of action for dealing with BOPs, pharmacies will be better positioned to navigate the increasingly complex pharmacy landscape.

By developing a plan of action for dealing with BOPs, pharmacies will be better positioned to navigate the increasingly complex pharmacy landscape. Image Credit: © neirfy - stock.adobe.com

State Boards of Pharmacy Are Essential to Operate a Pharmacy

On one hand, it is well known that BOPs are essential to operating a pharmacy since pharmacy licensure is one of the most basic prerequisites to operating a pharmacy. Most states have numerous requirements that must be met prior to opening a pharmacy and granting a license. As part of this process, BOPs will often conduct initial inspections. This can be one of the first opportunities a pharmacy has to meaningfully engage with its BOP, including local inspectors and other BOP personnel.

Obtaining a Pharmacy License Is the Beginning of a Pharmacy’s Relationship With its BOP

Although the process of getting licensed as a pharmacy in a given state is a time consuming and in-depth process, initial pharmacy licensure is merely the beginning of a pharmacy’s relationship with its BOP. Over the past several years, the importance of a pharmacy’s ongoing relationship with BOPs has taken on greater significance. This is due to several changes in the pharmacy marketplace including heightened scrutiny of the overall cost of health care and prescription medications, a general uptick in BOP activity like disciplinary actions, more frequent inspections, investigations, and increased communication between BOPs and PBMs.

Information Sharing Between PBMs and BOPs

In recent years, there has been a noticeable increase in PBMs sharing information with BOPs related to their private pharmacy audits. In fact, a noticeable pattern has been observed wherein PBMs share information regarding these private audits conducted of network pharmacies and in turn, BOPs initiate separate BOP investigations.

Although the basis for a BOP beginning an investigation of this sort may be a limited issue as presented by a PBM (which may or may not have merit), a BOP’s corresponding investigation is not necessarily limited to this issue. Rather, BOPs, as administrative agencies, often have great discretion to examine all aspects of a pharmacy’s operations and business practices. Therefore, pharmacies must remain vigilant to ensure they comply with all BOP rules and regulations. This preparedness will help them handle any unexpected investigations and ensure they are ready for a thorough review by the BOP.

Investigations and Other Actions by BOPs Usually Must Be Reported to PBMs

Making the situation even more challenging is the fact that all the major PBMs have contractual obligations to report any action by a BOP that is considered to be disciplinary in nature. Often, these reporting obligations may be triggered early in a BOP action, which could include even more basic BOP inspections or investigations depending on the language of the relevant contract. In these circumstances, if the pharmacy fails to accurately report such actions or conduct, the PBM will likely try to terminate a pharmacy for:

1. failing to report the BOP disciplinary action;
2. the substance of the underlying BOP disciplinary action; or
3. both.

Given these important implications, a pharmacy must have an in-depth understanding of its relationship with its BOP and its corresponding obligations (and contractual obligations with PBMs). Pharmacies must consider many factors including:

1. what BOPs are and their role as administrative agencies;
2. what are some of the most common oversights and mistakes made by pharmacies that lead to BOP disciplinary actions;
3. how these common oversights and mistakes can be prevented; and
4. the most common types of actions, including disciplinary actions, taken by BOPs.

Pharmacies Must Create and Implement a Strategic Plan for Success

With the understanding that a pharmacy’s relationship with its BOP is critical to its successful operation and long-term viability as a business, a pharmacy must be aggressive and proactive and develop a strategy for success as it relates to working with its BOP. One thing a pharmacy can do to build a strategy for success is to cultivate a positive and collaborative relationship with BOPs. There are many ways a pharmacy can become more involved with its BOPs. Examples include:

• attending BOP meetings (which are often open to the public and may be conducted virtually);
• contacting a BOP directly when questions or concerns arise;
• getting to know the individuals that sit on the BOP; and
• regularly communicating with BOPs when there are changes at the pharmacy (eg, personnel changes, hours of operation, location).

A pharmacy should also learn more about the legal rights afforded to pharmacies under their BOP’s laws, rules, and regulations so that if an issue does arise, they can handle it properly and promptly and, where appropriate, involve legal counsel. Pharmacies should also develop a process and procedure for monitoring any new rules or regulations that are enacted by a BOP so that if a new requirement is enacted, the pharmacy can act promptly to ensure compliance. BOPs will rarely overlook any noncompliance, even if it was due to a pharmacy not being aware of newly enacted obligations.

Pharmacies Should “Partner” With BOPs in Pursuit of the BOPs Mission

Pharmacies should also understand what their BOP’s mission is—these are often readily available through the BOP’s website. For example, the Texas State Board of Pharmacy states its mission as follows:

The Texas State Board of Pharmacy, as a leader in protecting the public health of the citizens of Texas, shall uphold quality standards for licensing and facilitate regulation that promotes innovative, multidisciplinary, and collaborative practices and education, which produce quality care and positive patient outcomes.

By understanding a BOP’s mission and role in protecting the health and wellbeing of the citizens in their states very seriously, a pharmacy will be better positioned to work as a partner with its BOP knowing the mission is important as a starting point. From there, it is critical that pharmacies meet the BOPs’ expectations for the licensees they oversee head-on. By cultivating a strategy for success and focusing on prevention, as well as being proactive and accountable, pharmacies will be better equipped to interact with their BOPs. If it does become necessary to deal with a BOP in an active disciplinary action, prior steps taken to prevent or address issues are often rewarded by BOPs.