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Public Policy Update – Standards Based Regulation – The Big Picture

18 Mar 2021 4:51 PM | Anonymous

By Nathan Hanson, PharmD, MS, BCPS; Healthtrust Supply Chain

Quick Question: Are you compliant with the Board of Pharmacy rule that establishes the minimum size for the pharmacist’s photo that is posted in a pharmacy?

Next Questions: If you are noncompliant with this rule, will patients be negatively impacted? If you are compliant with the rule, will patients benefit?

Most Important Question: Why is this rule in place?

Safety First

As you know, the Board of Pharmacy and the Department of Health have a simple goal: Protect the safety of the public. This important goal is the reason that their employees go to work each day, and it is the reason that the board members read and meet and debate and decide. This goal is noble, and the public trusts them to carry it out. Pharmacists are trusted professionals, and I believe that our diligent regulators share some of this credit. Because of their oversight, patients can trust the pharmacy profession.

How Best to Achieve Safety?

For many years, the favored approach to achieving public safety has been to create a system of robust rules that make it very clear what the pharmacists and technicians must do. These rules are detailed, and they spell out what is allowed and especially what is not allowed. This could be called the “Restrictive Approach.” The beauty of this approach is clarity: every pharmacist-in-charge can read the rules and know what is expected. Every inspector can give a clear answer about most questions, because everything is written down. The detail provides clarity and consistency, and the detail provides firm and irrefutable justification for an inspector to hold a pharmacy accountable when it is putting their patients at risk. (And trust me, there are some pharmacies out there that are not operating at the level that you and I would expect.)

At What Cost?

But is that still the best approach to patient safety? A potential unintended consequence of this approach is that the reason for the rule is obscured by the regulatory burden from the rule. In other words, the rules were written with good intentions to create a certain safe outcome, but sometimes the end result is that the complicated and detailed rules actually get in the way of safe care. Sometimes these inflexible rules limit the creative solutions that a pharmacy team has developed, or they divert so much time and energy to ‘checking the box’ that it is no longer feasible to offer cutting edge services that the patients really need. And sometimes a pharmacy can be following the specific ‘letter of the law’ and meeting the minimum standards, but are still clearly not providing good care.

Start with Why

These pharmacy rules can be very specific in “What” they require, but it is easy to forget “Why” they exist. For example, it is important for patients to know and trust their pharmacists, and so there is a requirement to post the pictures of the pharmacists. Obviously those pictures need to be large enough that the public can actually see them. And so, 20 CSR 2220-2.010 specifies the minimum size of the photo: 2” by 2”. This is a great example of a very specific rule to achieve an important “Big Picture” (sorry for the dad joke) goal. But is there another way?

Standards Based Regulation: This Changes Everything

Because of these gaps in our current approach, the Board of Pharmacy is beginning to shift towards an innovative concept called Standards Based Regulation. At a recent Board of Pharmacy webinar, Executive Director Kim Grinston gave a great description of the Board’s new approach to rule-making that they have been adopting over the past 2 years. I highly recommend that you click on the link and listen to it. It is a brief, 5 minute explanation, from 3:25 to 8:00 on the recording, and you will get a very clear understanding of the Board’s position on this exciting new approach. Some of her quotes are as follows:

“The goal of standards based regulation is to encourage professionals to use their professional judgment instead of listing very restrictive requirements that may not accommodate all scenarios.”

“The goal of standards-based regulation is to clearly identify what the safety standard is…and then allowing licensees to determine how to best meet that standard.”

“We want to get out of your way and let you be the experts that you are, and the standards based approach allows us to do that.”

This is an excellent summary of an exciting new approach. I believe that it will allow the pharmacy profession to modernize and advance. As barriers are removed, we will be able to provide our patients with the care that they need, and we will be able to focus our attention on solving the right problems and creating the right solutions to keep our patients safe.

Fill the Gap: Freedom Requires Responsibility

This is a new way of thinking! How will we handle it? Will we be able to continue to provide safe care to our patients as we are given more freedom and flexibility? This won’t be an overnight change, but as rules are changed and more flexibility is granted, I believe there are 2 things that we need to do. First, we need to raise the bar for ourselves, and make sure we are thinking about the best way to provide excellent care to our patients. Not just the bare minimum. Second, MSHP needs to step in and provide clear best practice guidance about areas where the rules have given us professional flexibility. Our Tech Check Tech guidance document is a recent example of this. We must continue to partner with our members and leaders from other organizations to paint the picture of ‘what good looks like.’


Remember, our patients trust us, and the Board of Pharmacy trusts us. Let’s rise to the occasion and demonstrate that their trust is well-placed. If we keep patient safety at the forefront of every decision that we make, I believe that we will do just that!


March 2021 Board of Pharmacy Webinar: https://vimeo.com/52010547520 CSR 2220-2.010 (Page 4 of the pdf)

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