In 48 states, pharmacists’ scope of practice allows for collaborative practice agreements (CPAs) with prescribers. But exactly which pharmacists can collaborate, with whom, and under what circumstances vary greatly from one state to the next. Some states restrict collaborative practice to certain settings; others limit collaborations to those between physicians and pharmacists only and no other prescribers.


This year, the National Governors Association released a paper, The Expanding Role of Pharmacists in a Transformed Health Care System, which offered broad recommendations to alleviate unnecessary restrictions in collaborative practice laws and regulations. To build on those suggestions, the National Alliance of State Pharmacy Associations (NASPA) convened a collaborative practice workgroup. This July, NASPA released the workgroup’s report, Pharmacist Collaborative Practice Agreements: Key Elements for Legislative and Regulatory Authority. It offers clear guidance on which aspects of collaborative practice authority should be codified in state laws and regulations, and which aspects should be left to the discretion of the collaborating providers. 


“The variability and sometimes restrictive nature of how collaborative practice authority is defined in state laws and regulations has made broad-scale uptake across the United States a challenge,” said Anne Burns, BSPharm, Vice President for Professional Affairs at APhA, who took part in the workgroup. “The NASPA workgroup report provides recommendations that promote optimal design of collaborative practice authority at the state level.” 


Barriers to collaborative practice


The workgroup members took inventory of the existing elements of collaborative practice authority across the United States. 


Requirements of annual agreement renewals, numerous signatures, and other bureaucratic tasks create unnecessary burden for providers in many states. “Practitioners, not states, should set a timeframe for when it’s clinically appropriate to update or renew an agreement,” said Krystalyn K. Weaver, PharmD, Director of Policy and State Relations at NASPA.


Some states only permit pharmacists who practice in health care facilities, not community pharmacies, to enter into CPAs. Regardless of the practice setting they ultimately choose, all pharmacists receive the same training in pharmacy school, Weaver said. “It’s about the patient and the practitioner, not the place the practitioner practices.” 


Discrepancies in regulations from one state to the next create barriers to implementation for chain pharmacies that operate across several states. In a state where pharmacists can collaborate with nurse practitioners or physician assistants, for example, in-store clinics are rich with opportunity. But it may not be cost effective for a national corporation to roll out certain patient care services in only a small proportion of its stores where state laws allow it. “Our pharmacy chain partners have a difficult time implementing these services when the laws vary so much state to state,” Weaver said.


State laws and regulations don’t always reflect pharmacists’ training and skills, nor do they always allow patients to get the best possible, evidence-based care. The workgroup sought to make recommendations that would align pharmacist scope of practice laws and regulations with the education and training that pharmacists receive to provide patients optimal care without any unnecessary regulatory burden.


The recommendations


The report recommends that state collaborative practice acts explicitly allow the following:


• Any prescriber may collaborate with pharmacists.

• Single or multiple pharmacists/prescribers may be parties to one agreement.

• Single, multiple, and populations of patients can be on one agreement.

• Initiation and modification of drug therapy can be authorized in the agreement.

• All medications, including controlled substances, may be managed under the agreement.

• The agreement should be available upon request to the board of pharmacy. 

• The report recommends that states remain silent on the following elements and allow practitioners to address the elements in individual CPAs at their discretion:

• Specifically list which pharmacists and prescribers are included in the agreement. 

• Identify any pharmacist training or credentials necessary to provide delineated services.

• Identify which specific patients or patient populations are included in the agreement.

• Specify which disease states are being managed.

• Specify which specific services are included.

• Specify if/which protocols or clinical guidelines are to be followed.

• Specify an appropriate level of patient consent for services.

• Specify the timeframe for renewal of the agreementt.

• Specify the documentation processes.

• Specify the liability insurance needs, if any.

• Identify the continuing education requirements for participation.



Arizona


The first collaborative practice act in Arizona, passed in 2000, restricted the types of settings where pharmacists could collaborate. “It was federally qualified health centers and hospitals. It didn’t lend itself to use in private practices or in a community pharmacy setting,” said Sandra Leal, PharmD, MPH, who was the medical director of clinical pharmacists at El Rio Community Health Center, a federally qualified health center, from 2001 to 2014.


Her practice site among the first to implement collaborative practice agreements (CPAs) in the state, Leal has seen collaborative practice authority evolve over the years. “Initially, very few people were utilizing it,” she said.


If it wasn’t the site restrictions, it was the onerous documentation requirements that turned pharmacists away. Pharmacists had to have a CPA with each individual physician in their practice, and patients had to sign the CPA, too. “We literally had to get permission from each of the 50-plus providers at the health center to work in collaborative practice with them as individuals.” And the agreements had to be renewed every year. “It would take us several months to get everyone’s signature,” she said.


The increasing digitization of health records over the years has helped to reduce some of the paperwork burden. And the results of 10 years of collaborative practice helped Arizona pharmacists make the case for a number of amendments to the law in 2011.


“We had a decade of success and evidence of actual improved patient outcomes,” said Leal, who is now Vice President for Innovation at SinfoniaRx. 


Today, Arizona pharmacists in any setting can collaborate with both physicians and nurse practitioners. The collaborators are no longer required to renew their agreements every year. Designated parties can approve agreements on behalf of a group of prescribers, which eliminates the need for separate agreements with every provider in a practice.

Minnesota


Minnesota pharmacists have had collaborative practice authority since 1999. In the 16 years since then, as pharmacists have exercised that authority, when they discovered barriers written into the law, pharmacists worked to change it.


Early iterations of Minnesota’s collaborative practice act stated that CPAs were limited to one pharmacist, one physician, and one patient. When that stipulation proved a hindrance to pharmacists taking care of patients under CPAs, pharmacists worked to change the rule. The law then allowed for agreements between multiple pharmacists and physicians to care for multiple patients. Today, the law allows pharmacists to collaborate with nonphysician prescribers as well.


“Every time we went back and made a change, pharmacy had to prove that they could do it,” said Julie K. Johnson, PharmD, former Executive Vice President and CEO of the Minnesota Pharmacists Association. “Then with each year and each success, pharmacists educated patients and other providers that we could do more. That just helps.” Johnson shared her experiences in Minnesota with the NASPA workgroup. “Progressive states have an obligation to work at the national level … to help other states do what they’ve been able to do.”

South Carolina


The NASPA workgroup recommends that state practice acts use language that is broad enough to not inadvertently limit what pharmacists can do. South Carolina has avoided that problem enough to allow opportunities for pharmacists, said Bryan Ziegler, PharmD, Executive Director of University of South Carolina’s Kennedy Pharmacy Innovation Center. 


“We were very fortunate that 20 years ago, when our practice act was last updated, they used broad terminology,” Ziegler said. “They included things such as designing, implementing, monitoring, and managing therapeutic plans related to patient care, and also being able to provide drug therapy management in collaboration with other providers. This language allows pharmacists to practice at the top of their license and utilize their training and expertise in direct patient care.”


But regardless of the liberal language, “unfortunately, South Carolina’s pharmacy practice act provides little guidance on collaborative practice agreements,” Ziegler said. “Pharmacists have to look at the medical practice act for information on this.”


South Carolina’s medical practice act defines CPAs and only allows pharmacists to collaborate with physicians. “While there is a lot of opportunity to work directly with physicians, one limitation that we’re going to face going forward is the opportunity to work directly in a collaborative agreement with nonphysician providers like PAs [physician assistants] and nurse practitioners.”


Community pharmacists in South Carolina are missing an opportunity to collaborate with the nurse practitioners or PAs that might be running clinics right inside their store.


“Those clinics are now taking on conditions such as diabetes, hypertension, and hyperlipidemia—complex medical conditions that routinely involve a variety of drugs,” said Ziegler. “That scenario is a prime opportunity for a nurse practitioner to collaborate with a pharmacist to make medication interventions and adjustments.”