On The Cover
Loren Bonner
Need another training course to prescribe oral contraceptives or perform HIV testing and prevention? As states advance pharmacists' scope of practice, they're adding more training requirements for pharmacists, ignoring that pharmacists—like other health care providers—have professional responsibilities and are educated and trained.
“We are the most regulated profession there is,” said Jennifer Adams, PharmD, an associate professor and associate dean for academic affairs at Idaho State University L.S. Skaggs College of Pharmacy.
Typically, if a law does not expressly allow a pharmacist to perform a duty, the duty is interpreted as being prohibited.
Enter standard of care regulations. The framework removes the regulatory burden on states to write detailed rules on how to implement and enforce legislation for pharmacy practice. A few states have already moved in this direction, including Idaho, Alaska, and most recently Iowa.
“In a standard of care model, each person involved in a patient’s care can practice to the top of their ability. This removes the need for continually needing to go to the legislature and ask for one more test to be added to the approved list, one more vaccination, or one more clinical service,” said Julie Akers, PharmD, associate professor and associate dean of external relations at Washington State University College of Pharmacy and Pharmaceutical Sciences. “It greatly simplifies the process, putting the onus on the care provider themselves to ensure they only participate in care provision that they are prepared to do.”
Physicians, nurses, and all other health care providers are regulated with a standard of care model.
How to implement a standard of care regulatory model for pharmacists
Authors of the February 11, 2024, paper in
Adapted with permission from Adams,. 2024. https://doi.org/10.1016/j.japh.2024.02.007
“Pharmacists are the only doctorate level–trained health care professional I know of who are not regulated this way,” said Akers.
In Indiana, pharmacists can independently prescribe hormonal contraception. Veronica Vernon, PharmD, practices in Indiana and has been working in women’s health for over a decade as an ambulatory care pharmacist, but Indiana’s board of pharmacy requires her to take a CPE course to prescribe hormonal contraception.
“Pharmacists need to determine what they need,” said Vernon, assistant professor and vice chair of pharmacy practice at Butler College of Pharmacy and Health Sciences in Indiana. “I have no business prescribing oncology medications and I would like to think I would need the training if I have been out of the loop on birth control, for example.”
With brightline regulatory models, Akers said the profession is regulated to the pharmacist with the lowest clinical ability. A brightline rule is a clearly defined rule or standard, leaving little room for interpretation.
“This stifles innovation and prohibits licensees from practicing at their highest level of education, training, and experience,” Akers said.
Idaho
Idaho has had a standard of care framework in place since 2018.
Idaho was the first state to allow pharmacy technicians to administer vaccines, for instance, because in a standard of care regulatory framework, pharmacists can delegate this to trained technicians. The pharmacist decides what can be delegated and to whom, rather than a one-size-fits-all protocol established by a board of pharmacy that may impede high-performing technicians from practicing to the top of their own education, training, and experience, said Adams and fellow authors of a February 2024 commentary in JAPhA on “How to implement a ‘standard of care’ regulatory model for pharmacists.”
In fact, during the COVID-19 pandemic, the PREP Act mimicked the Idaho law for COVID-19 vaccinations in pharmacies.
Authors of the JAPhA commentary wrote that “If laws do not provide flexibility for practice advancements, laws will routinely lag behind, and patient care will suffer as a result.”
They give the example of vaccinations. Prior to 1994, pharmacists administering immunizations was nonexistent, and rigid laws meant it took 15 years for all states to legally allow it. “Given that pharmacies are now the venue of choice for patients seeking vaccines, how many vaccine-preventable illnesses could have been avoided in that 15-year legal slog if pharmacists had the ability to serve patients more proactively?” they wrote.
They go on to say “What services, yet uncontemplated, may predominate in pharmacy in 10, 20, or 30 years? Rather than try to speculate, Idaho set up a legal structure that allows elasticity for future growth.”
The standard of care regulatory framework allows practice to evolve over time without the need for constant law changes.
Not only does standard of care provide pharmacists with flexibility in practice, but it holds them accountable if they deviate from what other prudent pharmacists would have done in the same or similar situations.
Iowa gets started
On April 22, 2024, Iowa governor Kim Reynolds signed a bill into law that updated the state’s pharmacy practice act and put in place a standard of care regulatory framework, aligning pharmacists with other providers in the state.
Iowa’s Pharmacy Practice Act was last fully rewritten nearly 40 years ago, according to Kate Gainer, executive vice president and CEO of the Iowa Pharmacy Association (IPA). The new bill reduces the state’s practice act from 27 pages to 16 pages.
“Significant pieces that were added,” said Gainer, “are the standard of care definition and ‘pharmacist’ to the definition of practitioner.”
Significant pieces that were removed, she added, include brightline lists of duties that technicians can or can’t do, and brightline lists of which statewide protocols can be implemented.
“Strategy and timing are always important considerations when advocating for a pharmacy priority,” said Gainer. “Following years of work by IPA’s Practice Act task force, IPA’s legislative priorities included ‘Modernize the Pharmacy Practice Act’ for 2 years before we ever introduced a bill.”
In 2023, there were other factors that created a favorable political environment for introducing the pharmacy practice act rewrite in Iowa.
Akers said that some skeptics have suggested it was easy to adopt less regulation, which the standard of care provides, in a conservative state like Idaho. However, as Adams and fellow authors of the JAPhA commentary pointed out, an increasing number of states, whether blue or red, have adopted a standard of care regulatory model for nurse practitioners.
“Interested stakeholders should draw parallels to existing regulatory structures for other health professions within their own states and educate lawmakers about the commonalities between such professions, noting the benefits of the flexible standard of care approach,” said the JAPhA commentary.
“Changing legislation to allow for a standard of care model may be easier in a conservative state when using the argument that less regulation is better. But it isn’t the only way forward,” said Akers. “In many states, like Washington, there is an extreme provider shortage. There is not one county in Washington state that does not have some form of provider shortage. Removing restrictive and unnecessary legislative barriers that currently inhibit providers practicing at the top of their training and experience should be something everyone can get behind, regardless of their political affiliation.”
Akers said that Washington state is still in what she refers to as “the discovery phase” of a standard of care framework for pharmacy. “It will likely take several years to adopt, as major amendments would need to be made to statutes overseeing pharmacy practice, both from a facilities and practitioner standpoint,” she said.
To inform pharmacists about standard of care in Iowa, Gainer said they have launched a resource page (www.iarx.org/soc). They have also hosted a one-day Standard of Care Symposium and created an FAQ where questions can be submitted online at any time.
“The Board of Pharmacy will be reviewing the entirety of its administrative code chapters to align regulation with the new practice act. It is anticipated those rules will be finalized in spring of 2025,” said Gainer.
The Iowa bill’s effective date is July 1, 2024, but pharmacy practice changes will take longer to implement.
APhA adopts policy on standard of care regulatory model for state pharmacy practice acts
In 2022, the American Pharmacists Association House of Delegates adopted a policy statement requesting that state boards of pharmacy regulate pharmacy practice using a standard of care regulatory model. APhA policy notes that other health professions have adopted this regulatory model and postulates that it would allow pharmacists to practice “at the level consistent with their individual education, training, experience, and practice setting.”
APhA requests that state boards of pharmacy and legislative bodies regulate pharmacy practice using a standard of care regulatory model similar to other health professions’ regulatory models, thereby allowing pharmacists to practice at the level consistent with their individual education, training, experience, and practice setting.
To support implementation of a standard of care regulatory model, APhA reaffirms 2002 policy that encourages states to provide pharmacy boards with the following: (a) adequate resources; (b) independent authority, including autonomy from other agencies; and (c) assistance in meeting their mission to protect the public health and safety of consumers.
APhA encourages NABP as well as state and national pharmacy associations to support and collaborate with state boards of pharmacy in adopting and implementing a standard of care regulatory model.
APhA and other pharmacy stakeholders should provide educational programs, information, and resources regarding the standard of care regulatory model and its impact on pharmacy practice.
More support
Adams is not surprised that in the 6-plus years since Idaho adopted the standard of care framework, their board of pharmacy has not received one complaint related to a standard of care violation. The number of disciplinary cases the board has adjudicated has not increased either.
“Pharmacists are risk averse,” she said.
In order to provide sustainable care in a standard of care model, pharmacists need to be paid for their services.
“As states transition to a standard of care model, with a goal of increasing access to care, they need to have state level systems in place to ensure sustainability,” said Akers. But sometimes that’s not enough. “This [payment for services in Medicare] has to change at the federal level, in addition to in states that do not already have this in place, to truly realize the benefits of a standard of care model.”
In Iowa, the new practice act has no reference to payment for pharmacist services. Gainer said pharmacists in Iowa have already discussed a few strategies, including health systems working with their billing department and leadership to add pharmacists to bill for services; and in community pharmacy settings, pharmacists could submit claims through both medical and pharmacy billing software, as well as set up cash-based services.
“IPA advocates to payers in the state on the role and value of the pharmacist—and will continue to do so following the passage of [this bill],” said Gainer. ■