Report of the 2020-2021 Strategic Engagement Standing Committee

Background

As the COVID-19 pandemic unfolded in the United States (US) in 2020, unprecedented federal expansion of scope of practice (“Scope”) for pharmacists¹ has been implemented by the US Department of Health and Human Services (DHHS) via the PREP Act.² This Act allows pharmacists in all states and territories to order and administer COVID-19 testing and the vaccines recommended by the Centers for Disease Control Advisory Committee on Immunization Practices for patients ages 3³ to 18. In October 2020, US DHHS expanded the scope of pharmacy technicians and pharmacy interns to allow immunization administration.⁴ US DHHS provided additional clarification in late October 2020, that the PREP Act guidance supersedes state law that is more strict, but does not take away broader authority granted by states.⁵ The PREP Act provides healthcare providers immunity from liability claims with the exception of willful misconduct.

State boards of pharmacy also took steps, via emergency regulation, to allow pharmacists expanded scope of practice in order to contribute to efforts in controlling the COVID-19 pandemic. Examples of these efforts include: multi-state licensure; more permissive telehealth regulation; point-of-care-testing (POCT) authority expansion; authority to order and interpret labs; therapeutic interchange authority; and pharmacy technician/intern immunization administration authority.

These expansions of scopes pharmacists, pharmacy interns, and pharmacy technicians at both the federal and state level are temporary while the pandemic continues as a national public health emergency. Given the temporary nature of the expansion, the question arises, that if we needed pharmacy personnel available to provide these services during a pandemic, shouldn’t these services be provided by pharmacy personnel, post-pandemic? In order to provide quality care during an emergency, healthcare providers need practice with these services. If pharmacists practice at a higher scope every day, there are fewer exceptions to accommodate and less need to modify workflow and train on new services during an emergency, resulting in a higher overall quality of care provided. During the COVID-19 pandemic, pharmacists have increased patient access and have safely provided COVID-19 testing and vaccinations. A theme across the missions of state boards of pharmacy is to protect the public health, and providing access to high quality care improves the public health. With 90% of Americans⁶ living within 5 miles of a community pharmacy, access to services necessary to combat the pandemic can be attained. While the federal government has covered the cost of the vaccines and has provided supplemental funding to support access during the COVID-19 pandemic,⁷ payment for advanced patient care services provided by pharmacists in the future will be necessary for these services to be sustainable.

Recommendations to Outside Organizations

During the COVID-19 pandemic, key aspects of pharmacist scope expansion have been identified by federal and state regulators. Pharmacists’ ability to independently order and interpret labs, order vaccines, and prescribe and administer medications have increased access for patients to life-saving services during the pandemic. The committee recommends that advocacy strategies be developed to update state statutes and regulations allowing pharmacists to perform these services independently in all US states and territories, permanently. Advocacy strategies work best when all parties have input on the approach and agree on the core objectives; in this case, sustaining temporary pharmacist scope of practice expansion to provide emergency-and-pandemic-ready scope of practice.

The National Alliance of State Pharmacy Associations (NASPA) has been engaged in this work and has previously provided consensus recommendations on medication administration, collaborative practice agreements (CPAs), and state-wide protocols.⁸ The committee reviewed these recommendations and identified the following areas to be re-visited and considered to assist advocacy efforts and support the stated objective of sustained scope of practice expansion post-pandemic:

CPAs

• Continue to support the model that allows all licensed pharmacists with appropriate training to participate in CPAs, and does not restrict participation to subset of licensed pharmacists

• Continue supporting the population model of CPAs which increases patient access and does not add undue regulatory burden to the process

• Discourage use of patient-specific CPAs in meeting public health needs

• ○ Patient-specific CPAs are ineffective during a public health emergency

• Encourage state boards of pharmacy to outline processes of emergency CPA amendment that are simple and easy to implement during a state of emergency

• Encourage state boards of pharmacy to evaluate their general CPA amendment process, allowing CPAs amendments to be determined by the parties in the CPA without need for prior approval by the board of pharmacy or another other health licensing board

• Continue to assert that no statute or regulation should require the agreement to be ‘on file’ or be approved by the board of pharmacy or any other health licensing board

• Keep the following as a guiding principle for all recommendations - the more permissive the practice, the more prepared the practitioners will be in an emergency

  State-wide protocols

• Encourage use of state-wide protocols over state-wide standing orders, since the latter present significant challenges to sustainable patient access to care

• Encourage language used in state-wide protocols to be flexible enough to account for changing practice standards that would require rule update

• ○ Outdated protocols can create challenges for payment if payers require processes based on these protocols

• ○ Referencing accepted guidelines used in patient care rather than including specific details in the protocol itself can help prevent this issue

Medication administration

• Encourage states to adopt generic language in statute (eg, in the pharmacy practice act) that allow for administration of any medication

• ○ Clinic closures during COVID-19 added need for other medications beyond vaccines (e.g. long-acting antipsychotics, long-acting antibiotic treatments for STIs, etc.)

One of the many resources provided to boards of pharmacy by the National Association of Boards of Pharmacy (NABP) is the NABP Model Practice Act.⁹ The committee reviewed the current iteration of the NABP Model Practice Act and identified the following areas to be re-visited and considered to assist advocacy efforts and support the stated objective of sustained scope of practice expansion post-pandemic:

• Recommend updating institutional versus other settings

• ○ Do regulations need to be separated based on practice setting, or should pharmacists be held to the same standard of care regardless?

• Add section on multi-state licensure (similar to nursing licensure compact) and include consideration of the impact on the following areas:

• ○ Temporary licenses (including NABP Passport program)

• ○ Shared pharmacy services

• ○ Telepharmacy

• Include the word administration in the definition of the practice of pharmacy (Article I, section 104) allowing for administration of any medication

• Consider renaming ‘chart order’ to ‘institutional order’ to use contemporary language (Article 1, section 105)

• Consider combining Medication Therapy Management (MTM) with Pharmacist Care Services section (Article 1, section 105)

• ○ Add order and interpret labs (make explicit as independent act)

• ○ Include footnote caution about using ‘or’ versus ‘and’ (to prevent the situation where if a pharmacist does not complete all MTM steps then it is not legal)

• ○ Check for alignment with the Joint Commission on the Pharmacy Practitioner’s Pharmacist Patient Care Process (PCPP) and consensus definitions - state laws should not be a barrier to pharmacists providing services related to the PCPP that has been broadly adopted by the pharmacy profession

• Update primary care definition without use of protocol to allow for the independent services currently allowed in some states

• Add and define prescription adaptation as authority allowing a pharmacist to adapt drugs as needed by changing quantity, dosage form, and completing missing information (see Pharmacist Care Services section)

• Add and define therapeutic interchange as substitution of a drug with another drug in the same therapeutic class (see Pharmacist Care Services section)

• Add #19 Standard of Care to Grounds, Penalties, Reinstatement – acts or omissions within the practice of pharmacy which fail to meet the standard provided by other qualified licensees or registrants in the same or similar setting [(Article IV, section 402(a)]

• Model Rules for Institutional – all could be combined with a general section [Section 4(e)(f)]– could be included with remote dispensing

• Model Rules for the Practice of Pharmacy

• ○ Recommend a new section to outline how pharmacists delegate authority to technicians

• Pharmacist Care Services – Rather than including most of the increased scope allowances seen during the pandemic as a footnote, move to the main section and provide model language for those activities

• ○ Add a section about treatment for public health and prevention (eg, vaccines, naloxone, smoking cessation, hormonal contraceptives, POCT prescribing, etc.)

• ○ Add prescription adaptation and therapeutic interchange to this section

• ○ Emergency use dispensing prescribing – move footnote to the section and include independent authority and add glucagon

• ○ CPA – consider streamlining, and use the word initiate instead of generate

• Model Rules for Public Health Emergencies

• ○ Section 4(a) extend refills for a reasonable amount of time rather than dictating 30 days

• ○ Consider addition of compounding medications in short supply

• ○ Consider a section with guidance on how to reasonably address potential stockpiling medications during an emergency versus legitimate patient access

• Model Rules for Telepharmacy

• ○ Review with a remote working perspective

•  ▪ Could the supervising pharmacist work from home?

•  ▪ Could the technician work from home?

•  ▪ Consider this for shared pharmacy services as well

• ○ Address the disconnect between the definition of the practice of telepharmacy and the Model Rules which focus on product dispensing and the building, rather than the services and the staff

Recommendations to AACP

The committee believes that in addition to actions needed from outside organizations, individual AACP members, member institutions, and AACP staff will need to take action for sustained expansion of pharmacist and pharmacy technician scope of expansion. Via proposed policy, the committee recommends that each institution designate a strategic engagement champion, who can lead efforts at their institutions. The two areas identified for these efforts that support the charge to advocate for sustained expansion of pharmacist scope of practice are advocacy education and communication. Regulatory approaches vary by state and navigating state statutes and regulations can be challenging, depending on how they are organized. The committee recommends that strategic engagement champions educate themselves about the regulatory approaches in their state and become familiar with various regulatory strategies that have led to more advanced practice, such as permissionless innovation¹⁰ and standard of care regulation.^11,12 The committee recommends that AACP, via the Center for Academic Innovation and Practice Transformation, develop a roadmap to identify and guide the focus of academic pharmacy advocacy efforts related to scope expansion.

Advocacy communication and building relationships are vital to sustaining the expanded scope. Building rapport with key stakeholders will allow strategic engagement champions and individual members of AACP to demonstrate the increased access to care that pharmacists have provided during the pandemic. This communication must continue to be internal to the pharmacy professional (eg, state associations, Board of Pharmacy, national pharmacy organizations, academic pharmacy leaders and members), and must also include external stakeholders. Engagement with external stakeholders, such as economists, public and private sector payors, public health professionals, and other health professions will be necessary so that pharmacists are not the only voices encouraging expanded scope of practice and increased public access to care.

CHARGE 3 SUBGROUP

Various examples exist from several states where interprofessional collaborations resulting in improved outcomes for patients. It is essential to learn how to build and approach effective interprofessional partnerships as pharmacy and medicine work together to improve patient outcomes while reducing health professional burnout, seen especially during the ongoing pandemic.

Survey

With the goal of building collaborations with medical colleges and the medical profession, an approach considered was to analyze potential barriers hindering pharmacists from participating more fully in patient care, as well as, to begin understanding any reservations or issues physicians have about collaborating with pharmacists. In a 2003 study, Law et al, conducted a survey comparing the perceptions of physicians, pharmacists, and patients on the unmet needs in the medication use process. Results showed that physicians and pharmacists had some similar views of unmet needs in the medication use process, however, they had different perspectives on how medication use can be improved.¹³

In 2021, Anandi Law of Western University of Health Sciences, will be repeating the aforementioned study examining stakeholders’ views called “Perception of Pharmacists in the Medication Use Process.” The purpose of the new survey is to analyze if and how the perceptions of physicians, pharmacists, and patients, nationally, have changed in relation to health care dynamics, and the developing role of pharmacists, using role theory as framework. With the updated scope of practice, pharmacists within interprofessional healthcare teams, and the incorporation of IPE in health profession schools, it is important to understand perspectives about pharmacists in order to overcome barriers and to enhance collaborative practice and optimize pharmacist services.

Due to the timing of the survey, Dr. Law is still working with her team to finalize the survey and begin data collection. Since this is a cross-sectional survey designed with online physician, pharmacists and patient panels, we believe the data and findings would be beneficial to the Academy and future Strategic Engagement Standing Committee in building out any future collaborations with medical associations and societies.

Meanwhile, in a more immediate approach to building collaborations with medical colleges, the committee was connected with Lisa Howley, Sr. Director of Strategic Initiatives & Partnerships in Medical Education, of AAMC to discuss how AACP and AAMC could begin potential joint programming. Dr. Howley explained the different programs AAMC runs throughout the year culminating with their large annual meeting typically held in the fall, that is widely attended. She further identified AAMC’s annual Integrating Quality (IQ) Conference as the setting that would be ideal to initiate brainstorming the potential programming. IQ’s focus is patient safety and quality improvement and it tends to be the most interprofessional conference attended by faculty, students and other health providers.¹⁴

Year 1 - Charge 3

Along with nursing (QSEN) and medicine (AAMC QIPS), AACP has been invited to represent pharmacy and participate in the 2021 Integrating Quality (IQ) conference that will kick off a potential three-year plan to outline how to further develop the partnership.

The current draft proposal from AAMC for the 2021 June panel at the IQ conference is Competency Based Health Professions Education in Quality Improvement and Patient Safety (QIPS): Opportunities for Strengthening Educational Partnerships

The COVID-19 pandemic and the worsening opioid epidemic have brought many challenges to our health and educational systems. However, they have also raised opportunities for partnerships across medicine, nursing, pharmacy and other professions. This session will provide examples of competency-based education in QIPS in three health professions and highlight strategies for continued interprofessional teaching and learning for better patient and public health. During this session, common competency themes across medicine (AAMC QIPS), nursing (QSEN) and pharmacy (AACP) will be shared and applied to several interprofessional educational areas including, drug safety, patient education and communication, COVID-19 vaccinations.

Session objectives:

1. Critique common quality improvement and patient safety competency themes across three professions

2. Apply these themes to interprofessional educational activities

3. Compare how these themes can be applied locally for interprofessional competency-based education

Several members of this committee will be attending the full conference, with the intent to network and gain a better understanding of the issues and discussions emerging from the field of medicine.

Following up on this panel is key to furthering the partnership with AAMC. Therefore, our recommendation is for AACP to lead a webinar event that mirrors the IQ panel discussion. The goal of the webinar should be to further discuss QIPS and highlight any new developments or changes. The planning will include Dr. Howley and AAMC, and showcase their work on this issue. It would be beneficial to participants if Continuing Education credit is offered to garner more attendance.

Year 2 - Charge 3

We encourage AACP’s key members and the 2021-2022 Strategic Engagement committee to continue the dialogue with AAMC in the fall of 2021 into early 2022. We propose INterim Meeting 2022 as the next potential event to follow up from the webinar. INterim could provide the optimal setting to raise awareness of the work and successes with AAMC over the past year. Also, given the nature of attendees at INterim, ie, deans and high-level faculty administration, it would be beneficial to gain their perspective and utilize the network of attendees to build a stronger partnership with AAMC.

A panel highlighting some key successes in interprofessional partnerships is recommended for the INterim Meeting. Following IN2022, the focus should then turn to Annual Meeting 2022 (AM2022) held in July. As this would most likely be the first in person setting for the academy since 2019, there will most likely be a large number of attendees eager to network. We encourage working closely with AAMC during the Spring of 2022 to develop a panel or workshop for AM2022 and engage high level representatives from both groups in joint programming in the form of a panel or workshop.

Year 3 - Charge 3

With the successful collaborations that are predicted to take place over the preceding 1.5 years (2021-2022), the focus should shift to how this partnership could be advanced. Over time, the intention is that schools and colleges of pharmacy and medicine can gain a deeper understanding of the importance of interprofessional collaboration. To that end, we suggest building out an AACP Institute program where members of the academy can collaborate with AAMC members.

The focus of the institute is to help faculty and leaders create stronger curricula that focus on interprofessional education (IPE) and patient care. This focus ties with the strategic planning of the academy in promoting innovative work at schools and colleges of pharmacy. An increased emphasis on innovation, especially in curricula, should be a springboard to collaborate further with AAMC and develop a framework on tying these interprofessional practices to curricular programs.