Purpose

To describe efforts starting in 2011 to simplify the regulation of pharmacy in Idaho and thereby encourage innovation by pharmacy practitioners.

Summary

The Idaho Board of Pharmacy reduced the number of words in its chapter of the state regulations by 11,715 words (26%) between 2011 to 2012. The primary emphasis was on eliminating obsolete regulations and restructuring the rulebook. These changes improved the readability and usability of the regulations without functionally changing how the agency regulated the practice of pharmacy. Over the next 5 years, the Idaho Board of Pharmacy added an average of 1,430 words back to its rule chapter annually. While these added details gave pharmacists permission to make innovations, the members of the board realized that the yearlong process of making changes was causing them to constantly lag behind advancements in the profession. The board decided to adopt a standard of care or “addition by subtraction” regulatory model. By eliminating 18,636 words (46%) in the regulatory chapter, the board established a flexible framework for pharmacists to identify what they can do or what technology may be used. Namely, if something is not expressly prohibited, the pharmacist can perform the task or use the technology if they can justify it as being consistent with their education, training, and experience. As a result, the regulations governing pharmacy remained at the reduced number of words in the ensuing years.

Conclusion

States looking to enable innovation in pharmacy practice should consider the “addition by subtraction” route and regulate based on a standard of care. Doing so has the advantage of enabling new practice models by pharmacists to emerge over time without having to go through the lengthy and change-resistant regulatory process.

A common way to measure regulatory burden is by volume, such as the number of pages published annually in the Federal Register, the aggregate word count across all published regulations or the total number of restrictive words (e.g., “shall” and “must”) used therein.1  In surveys, business leaders report that they perceive the overall volume of regulations as limiting to their decision-making autonomy and the economic outcomes of their companies.2  Thus, volume is a useful proxy measure of restrictiveness for regulatory reformers seeking to provide flexibility within a system and thereby increase innovation within a flexible framework.

In my experience running a state government agency — the Idaho Board of Pharmacy — measurement of regulatory volume uncovered an interesting finding: Not all volume is bad in the sense of adding to the regulatory burden, but increasing volume is highly suggestive of a regulatory model that is in desperate need of repair.

Figure 1 characterizes the growth (as measured by word count) in the Idaho Board of Pharmacy's regulations over a 20-year period. There was consistent year-over-year growth in word count until 2011, when the board undertook a major spring-cleaning effort to cut through the regulatory brush that had grown over the decades.

Figure 1.

Idaho Board of Pharmacy Regulation Word Count From 1998 to 2018

Figure 1.

Idaho Board of Pharmacy Regulation Word Count From 1998 to 2018

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This effort resulted in a reduction of 11,715 words (26%) between 2011 to 2012. The primary emphasis was on eliminating obsolete regulations and restructuring the rulebook. For example, 6 different definition sections scattered throughout the chapter were consolidated into a single, deduplicated section toward the beginning. These changes improved the readability and usability of the regulations without functionally changing how the agency regulated the practice of pharmacy.

Over the next 5 years, the Idaho Board of Pharmacy added an average of 1,430 words back to its rule chapter annually. For example, 400 words were added to enable new self-service automated dispensing systems. Another 50 words broadened the circumstances under which a pharmacist could substitute the medication written by a physician for a lower-cost one.

Additional changes provided flexibility for pharmacies to move more services to offsite locations, increased options for home delivery of medications, and allowed use of more forms of identification by patients picking up controlled substance prescriptions. Of note, each of these additions did not saddle licensees or the public with more red tape; rather, they added additional permissions, albeit at the expense of additional word count.

The challenge with enumerating every task or function that can be performed by a licensee in regulation, and all technology that can be used by licensees, is that it requires constant action by the agency to stay current in an evolving profession. Even still, with rulemaking action in Idaho taking approximately a year from start to finish under the Administrative Procedure Act, requiring this level of permission means that the regulations are constantly lagging behind advancements in the profession.

In some respects, adding permissions was reminiscent of how the heart compensates during heart failure. In the early stages, the heart pumps harder and masks the symptoms the patient would otherwise encounter, but the harder pumping can enlarge the heart and make the underlying problem worse. The more specificity added to the Idaho Board of Pharmacy regulations, the more the agency received hyperspecific questions that necessitated further regulation clarifications or additions. These questions led the agency's senior leadership team to disagree occasionally on whether the regulations allowed a specific form of technology or not, with the default being to add more regulations to remove any doubt. This approach to regulation was termed “compensated addition.” Ultimately, the board determined this was not an effective or sustainable model of regulation.

In 2017, the Idaho Board of Pharmacy took a new approach and stopped defining every task pharmacists could perform and every technology that could be used in the pharmacy. Instead, the new regulations established a flexible framework for pharmacists to identify what they could do or what technology may be used. Namely, if something is not expressly prohibited, the pharmacist can perform the task or use the technology if they can justify it as being consistent with their education, training, and experience.

The Idaho Board of Pharmacy offers 2 questions to help licensees successfully navigate this change in approach from prescriptive regulations to professional judgment3 :

  1. If someone asks why I made this decision, can I justify it as being consistent with good patient care and with law?

  2. Would this decision withstand a test of reasonableness (e.g., would another prudent pharmacist make the same decision in this situation)?

By adopting this approach, the Idaho Board of Pharmacy eliminated 18,636 words (46%) from the pharmacy chapter between 2017 to 2018. Unlike the previous foray into regulatory reform, the board has sustained this word count reduction over the ensuing 5 years. In fact, the agency has layered in additional cuts over that time, and no known public safety issues have been reported. This approach has been termed “addition by subtraction” or, more formally, governing according to a “standard of care.” Additional permissions can be granted while cutting regulations rather than creating a byzantine maze that is difficult for any licensee to navigate.

Idaho pharmacists now have full, independent prescriptive authority, including for controlled substances.4  They can adapt prescriptions (e.g., perform therapeutic substitution), administer any medication, perform any test, or delegate any appropriate task to pharmacy technicians. Economists have already suggested that these reforms have improved patient care in Idaho.5 

To further explore the connection between permissions and regulatory volume, the Pharmacy Regulatory Innovation Index (PRII) was created to assess pharmacy regulations in 10 Western states.6  The PRII scored state laws on the degree of innovation and flexibility. For example, if a state's laws allowed pharmacists to prescribe certain medications and administer vaccines. The PRII plotted a state's innovation score, as measured by which clinical services are allowable, against the same state's pharmacy regulatory volume, as measured by total word count.

In general, the states that had a high volume of regulation fell in the low innovation quadrant. By contrast, the states that rated as high innovation also fell in the low regulation quadrant. Further, while safety is poorly defined in the context of pharmacy regulation, no available evidence could be found that public safety outcomes varied based on a state's volume of pharmacy regulation.7 

Perhaps a surprise to California pharmacists is that the PRII categorized the state as “low innovation, high regulation.” California's pharmacy regulatory word count was 117,167 words, more than 4 times the length of those in Idaho. Yet, Idaho pharmacists still had more practice innovation allowances (95 versus 35), particularly regarding pharmacist prescriptive authority and technician delegation. California instead has focused in recent years on its Advanced Practice Pharmacist designation, which has high barriers to entry and low scope of practice gains.8 

That may change in the years ahead as the California State Board of Pharmacy has extensively studied a standard-of-care or hybrid approach to professional regulation “instead of using detailed and prescriptive protocols.”9  The board recommended adopting this approach for certain patient care services with “sufficient safeguards ... in place to ensure pharmacists retain autonomy to utilize professional judgment in making patient care decisions.”

Idaho's experience suggests that practice innovation and a low regulatory volume often go hand in hand. States looking to enable innovation in pharmacy practice should consider the “addition by subtraction” route. California is wise to consider a standard-of-care or hybrid regulatory model during the sunset review of pharmacy regulations in 2025.

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Conflicts of interest: Other than his employment with the state of Idaho, the author reports no relevant conflicts of interest with the material presented in this article.