Regulating pharmacist services: Achieving a full scope of practice

A few years before Tsuyuki et al. ¹ encouraged us all to use the phrase “full scope of pharmacy practice” in lieu of “expanded scope,” I was given a chart entitled “Pharmacists’ Expanded Scope of Practice in Canada.” ² Through a series of green checkmarks, it noted which provinces and territories allowed pharmacists to perform tasks like extending prescriptions, making therapeutic substitutions, ordering lab tests, administering drugs and prescribing for minor ailments (also before this term, too, was deemed denigrating). ³

Alberta swept the table, indicating that each expanded duty was allowed in its province, while other jurisdictions had to suffer the shame of a red “X” (not implemented) or a yellow “P” (pending legislation) next to select duties.

The chart was highly influential for me as I started my position at the Idaho Board of Pharmacy in 2015, a regulatory body of state government overseeing the licensure and practice standards of pharmacists, pharmacy technicians and their respective facilities, analogous to a provincial college of pharmacy. If Canadian pharmacists could perform these tasks, why not Idaho pharmacists?

At the time, Canadian pharmacist scope of practice seemed light years ahead of the United States. For example, many states were still painstakingly optimizing pharmacist immunization authority. Despite nearly 20 years of experience with pharmacist immunizations and a global H1N1 influenza pandemic that galvanized public health stakeholder support for expanded pharmacist roles, there were still widespread state-level limits on which vaccines pharmacists could administer and to whom, and minor legislative tweaks to these parameters often elicited strong inflammatory responses.^{4 -6} Pharmacists adapting prescriptions and independently prescribing seemed out of reach by some.

In the years since, Idaho has become the first jurisdiction in the United States to achieve a full scope of pharmacy practice with independent prescriptive authority that, arguably, exceeds Alberta.^7,8 Making this leap was facilitated by many of the articles published in the pages of the Canadian Pharmacists Journal that helped shift the debate from theoretical arguments to one that was rooted in evidence that demonstrated benefits to patient care. It was also an iterative process of creative destruction that saw the development and eventual elimination of a “minor ailments” prescribing list.

We found that often the best regulatory structure for pharmacists is the one that is permissive, not prescriptive, mirroring the regulatory approach in the medical and nursing professions. This commentary summarizes 3 of our key lessons learned along the way.

FAQs were indeed frequent—Respond with evidence

Tsuyuki ⁹ compiled the FAQs that accompany pharmacy scope of practice debates: questions about 1) fragmentation of care, 2) proper training and 3) conflict of interest. It is our experience that these questions transcend country borders.

Such is the nature of a scope of practice debate, the contours of which are often painted as theoretical “access vs safety” arguments. The insurgent profession—in this case pharmacy—emphasizes access. Undoubtedly, the pharmacy stakeholders will share how many licensees they have, especially in rural areas and health professional shortage areas, and thus patient access to care will naturally improve among underserved communities. The incumbent professionals will focus on safety, some even conceding treatment of common ailments, but with a twist: “Of course pharmacists can treat [common ailment X], but how do they know it’s [common ailment X] and not [rare condition Y] that can present similarly? They are not trained in differential diagnosis.” The incumbents will contend that safety trumps access, as access to unsafe care is no virtue.

It is critical to reframe a theoretical debate to one based on evidence and to address safety concerns head on with evidence of safety, not just access-oriented arguments. To do this, leverage the experience of other jurisdictions. For us, that meant focusing on the experience of Canadian provinces that had already allowed pharmacists to perform some of the duties we were pursuing, in some cases for many years, as we did not generally have other state examples aside from some limited studies tied to collaborative practice agreements (CPAs).

When we proposed adding urinary tract infections (UTIs) to the list of ailments that Idaho pharmacists could treat, for example, we were able to lean on the research of Beahm et al., ¹⁰ which found that pharmacists could appropriately manage uncomplicated UTIs safely and effectively and achieve high rates of patient satisfaction. Through this study and others, a picture emerged that pharmacists could diagnose and manage UTIs and do so in a manner than demonstrated wise stewardship of antibiotics.^10-13 Perhaps this is not a surprise, since women can reliably self-diagnose recurrent UTIs, and the same condition can be reliably treated over the phone by asking a few key questions.^14,15 Nonetheless, having objective evidence specific to the pharmacy profession was key to answering the FAQs in a manner that would resonate with a state legislative body.

Not all scope of practice debates will have evidence as compelling as that for UTIs, but often the absence of evidence may be evidence. If a service has been allowed in a state or province for years without any demonstrable patient safety issues, it can be reasonably be deduced as safe at the population level. ¹⁶ I often enquired of a provincial college of pharmacy how long pharmacists could prescribe for a specific condition and how many complaints alleging harm they received in the intervening time period. Perhaps not surprisingly, it was difficult to encounter any such cases. To our board of pharmacy, a track record of allowance in practice without complaints demonstrated safety.

“Minor ailments,” major headaches—Transition to a “standard of care” approach

Originally, we passed legislation that allowed the Idaho Board of Pharmacy ¹⁷ to designate through regulation which conditions qualified as “minor,” thus allowing pharmacists to diagnose and treat them. The first year, only 4 common conditions were included: 1) lice, 2) cold sores, 3) motion sickness prevention and 4) uncomplicated UTIs. Throughout the rulemaking process, there was considerable debate about the appropriateness of these being treated by pharmacists, as noted previously.

In the second year, the board announced regulations that expanded the list to include allergic rhinitis, mild cough and mild acne. ¹⁸ Of these, the most debate surrounded mild acne. A national dermatology group questioned the ability of pharmacists to appropriately diagnose and treat mild acne, despite studies suggesting that untrained patients can reliably self-diagnose mild acne.^19,20 Survey research from Canada showed that pharmacists prescribing for acne was of little concern to physicians relative to other conditions. ²¹ Further, acne was among the conditions most commonly allowed for treatment in provincial minor ailment schemes, and no evidence was reported that suggested it was unsafe.^22-24 It was this experience, though, that made the board question if it had the stamina to slowly and incrementally build out a minor ailment list over time and relitigate the FAQs for each. There had to be a better way.

In reviewing how both the medicine and nursing professions regulate in Idaho, neither had to constantly modify their scope of practice, and neither had an itemized list of ailments that needed to be refined over time. ²⁵ Both, instead, governed according to a “standard of care.” That means they have an elastic scope of practice that naturally evolves as education, training, experience, clinical guidelines and research change over time. Neither medicine nor nursing have an itemized scope of practice that constantly needs to be relitigated as things change, and therefore, neither faced constant legislative battles forcing them to justify their ability to perform certain duties.

Medical and nursing scopes of practice are thus flexible, but their regulatory boards still had the ability to pursue discipline in cases in which a physician or nurse deviated from the standard of care, that is to say, if the physician or nurse did something that other similarly situated practitioners would not have done in the same or similar situations. ²⁶ The facts of the specific case would be under scrutiny by the regulatory board, rather than a technical violation of prescriptive rules.

The Idaho Board of Pharmacy transitioned from designating every minor condition in rule to a standard of care approach.^27,28 The definition of “practice of pharmacy” now includes “prescribing of drugs and devices,” but it does not define which drugs or devices as a matter of law. ²⁹ Instead, pharmacists can now make determinations about what they can prescribe individually. If they are educationally prepared to prescribe statins, for example, pharmacists may do so if they also have the ability in their practice to monitor patient outcomes and make other appropriate decisions around the initiation and continuation of this drug category. ³⁰

Recognize the difference between law and practice

There is often a gap between law and practice. A law can allow pharmacists to provide a service, but it does not guarantee it will be provided in practice. Alberta prescribing is the classic example, as just a fraction of pharmacists obtained a prescribing designation more than 5 years after the law change conferring this scope of practice authority.^31,32

There are many barriers to providing a service in practice even if it is legally permissible. Patient acceptance, employer policies, payer policies and accreditation standards all have a role. As Rosenthal et al. ⁶ noted, sometimes pharmacists are even a barrier, as they are often characterized by risk aversion, a need for approval and paralysis in the face of ambiguity.

While limited uptake is often viewed as a disappointment by proponents of a law change, it also demonstrates that a law change does not immediately open a flood gate and thus there is a safeguard against unscrupulous practice. Too often, states try to facilitate uptake by adopting less ambiguous laws and requiring more standardization. One state adopted a 17-page protocol with standardized assessments for the prescribing of hormonal contraceptives. ³³ Another state has a standardized protocol and 7-page FAQ for pharmacists to use when prescribing naloxone, a drug so safe and effective that the US Food and Drug Administration recently approved it as an over-the-counter product to be sold in gas stations and vending machines.^34,35

In the United States, laws are slow and difficult to change. Even a board of pharmacy regulation can take a year or more to change from start to finish. Rather than calcifying protocols and standardized assessments and forms in law, this is where pharmacy associations should and must play a role. Associations may provide support through continuing education, standardized protocols, patient intake forms and treatment algorithms to help build pharmacist confidence in the delivery of services. Keeping these resources with individual associations instead of enshrining them in law makes updating them much easier, and resources can more naturally evolve as the practice environment evolves.

Conclusion

Canadian pharmacy scope of practice showed many state boards of pharmacy the way forward, and we are grateful for your leadership, your published research and your willingness to share your experiences. To truly accomplish a full scope of practice, a flexible regulatory framework is necessary. All jurisdictions should look to adopt a standard of care approach to regulation, buttressed by tools and resources from associations, to truly move practice forward for the betterment of patient care. ■