Implications for Pharmacies Navigating Shared Clinical Decision-Making in Vaccination

Introduction

The Advisory Committee on Immunization Practices (ACIP) has recently embraced shared clinical decision-making (SCDM) as a framework for certain vaccine recommendations. This type of recommendation seeks to foster health care decisions that are jointly made by patients and health care providers, emphasizing the need for detailed discussions over automatic vaccine administration.¹ Although this approach is commendable for its patient-centered nature, it introduces several operational challenges, particularly within the pharmacy setting.² These challenges are often exacerbated by the inconsistencies in state laws regarding pharmacists' scope of practice, despite their extensive training in patient assessments and clinical decision-making.

Pharmacies—particularly community, chain, and independent pharmacies—are crucial venues for implementing these new vaccination strategies, given their accessibility and frequency of interactions with the public.³ However, the SCDM model demands more than the traditional roles assigned to pharmacists, requiring an enhanced level of patient engagement, medical knowledge, and legal authority to implement effectively. Pharmacists face various legal and practical barriers across different states when trying to adopt SCDM in their practice.⁴

Image credit: © RAMBYUL | stock.adobe.com

Background

Before the adoption of SCDM, ACIP’s vaccination recommendations were straightforwardly divided into 3 categories: routine, catch-up, and risk based. These categories were primarily designed to simplify the vaccination process, ensuring broad coverage across various populations. The default action for each of these recommendations was vaccination. In contrast, the SCDM model introduced in 2019 marks a significant departure from this approach. It targets the personalization of health care by requiring that the decision to vaccinate be made after a detailed discussion between the provider and the patient, focusing on the specific needs and circumstances of the individual rather than broadly applied public health goals. Previously, this approach was known under various terms such as "Category B," "permissive," and "individual clinical decision making."¹

Given the personalized nature of SCDM recommended vaccines, pharmacies are uniquely positioned to facilitate these essential health care conversations; however, their effectiveness is frequently limited by significant legal and operational barriers. Pharmacists are among the most accessible health care providers in the United States, with 91% of the population living within 5 miles of a community pharmacy.⁵ This accessibility is further complemented by the operational hours of pharmacies, which often extend over weekends, unlike many physicians' offices.⁶ As a result, most adults tend to visit their pharmacists more frequently than their primary care physicians.⁷

The convenience offered by pharmacies has proven to be a critical factor in improving vaccination rates, as evidenced during the COVID-19 pandemic, when the majority of COVID-19 vaccine doses were administered in pharmacy settings.⁸ This trend is not limited to pandemic-related vaccinations; pharmacies regularly administer vaccines for influenza, shingles, pneumococcal disease, and human papillomavirus (HPV).³ The role of pharmacists was further expanded by a declaration under the Public Readiness and Emergency Preparedness Act, which authorized pharmacists and pharmacy technicians to vaccinate adults across all 50 states, leading to an increase in overall immunization rates.⁵ However, this expanded authority is set to expire in December 2024, potentially reverting the scope of practice and impacting vaccination efforts. Notably, independent pharmacies, which are predominantly located in rural areas, play a crucial role in providing health care services to underserved populations, thereby enhancing community health outcomes through increased vaccination accessibility.⁹

Challenges of SCDM

Implementing SCDM in the context of pharmacies presents a unique set of challenges. Firstly, the need for detailed patient-provider discussions as mandated by SCDM can be difficult to manage in high-traffic environments where pharmacists often handle multiple duties beyond patient consultations. These discussions require time, privacy, and a conducive environment that many pharmacies are not structurally equipped to provide and are not reimbursed for. Moreover, the legal scope of practice for pharmacists varies widely between states, which can restrict their ability to fully engage in SCDM without stepping beyond their legal boundaries.¹⁰

Another significant hurdle is the variability in patient health literacy. Effective SCDM requires that patients not only understand the information presented but also feel confident to discuss their preferences and concerns. Unfortunately, health literacy is not uniformly high across all demographics, and pharmacists often must tailor their communication strategies to effectively engage with each patient.^11,12 This necessity for tailored communication can strain pharmacists’ resources and limit the number of patients who can be served under the SCDM model.

SCDM Recommendations Highlight Complexities in Pharmacist Scope of Practice and Immunization Authority

Although the CDC recognizes pharmacists as vital health care providers capable of administering vaccines,¹ state-specific legal restrictions may limit their ability to initiate and administer vaccines. The legal scope of practice for pharmacists often fails to align with their professional scope of practice, which includes competencies such as patient assessment, vaccination, and medication prescribing developed through rigorous training. Despite their professional preparedness, pharmacists are frequently prevented by legal limitations from fully applying these capabilities. For instance, although pharmacists are trained to prescribe contraceptives and pre-exposure prophylaxis for HIV, only a limited number of states allow these practices.^13,14 This gap between training and legal authority hinders pharmacists' ability to conduct shared clinical decision making or administer vaccines that are SCDM-recommended.

Pharmacist immunization authority varies by state and can be categorized into 3 levels: independent, interdependent, and dependent. In states with independent authority, pharmacists can assess, prescribe, and administer vaccines without consulting other health care providers.

In states where pharmacists lack independent authority, cumbersome scope of practice conditions can delay the vaccination process and complicate the logistics of implementing SCDM. Specifically, in interdependent states, pharmacists need to collaborate with other providers through mechanisms like collaborative practice agreements, statewide protocols, or standing orders, which dictate their scope of action and may restrict their ability to independently conduct SCDM, despite allowing them to administer vaccines. In dependent states, pharmacists are limited to administering vaccines based on specific prescriptions and are not involved in the SCDM process.¹⁰

Conditional scope of practice can impede pharmacy-based vaccination particularly during busy periods, for vaccines that are newly recommended, or those have complex eligibility criteria. Moreover, the disparity in pharmacist authority from state to state creates inconsistency in health care delivery and can impact public health outcomes. For example, in states with more restrictive scopes of practice, pharmacists might not be able to offer vaccines that are part of an SCDM recommendation unless a physician is directly involved in each case. This not only limits the accessibility of vaccines but also burdens other health care systems and providers.

Conclusion

In the post-COVID-19 era, pharmacies have shifted from being the final stop in the patient journey to the initial point of contact for health care services. Given their professional scope to administer vaccines, their widespread availability, and their trusted position within the community, pharmacists are uniquely equipped to deliver preventive care.

The integration of SCDM into the routine practices of pharmacies represents a significant advancement in personalized health care, but also introduces complex challenges that need to be addressed. As pharmacies increasingly become focal points for public health initiatives, especially in vaccination, it is crucial that legal, educational, and financial structures evolve to support the expanded role of pharmacists. By addressing these challenges, pharmacists can be empowered to effectively implement SCDM, leading to better health outcomes and enhanced patient satisfaction in the vaccination process.

References

1. ACIP Shared Clinical Decision-Making Recommendations. CDC. Updated September 29, 2023. Accessed June 11, 2024. https://www.cdc.gov/vaccines/acip/acip-scdm-faqs.html

2. Shen AK, Michel JJ, Langford AT, Sobczyk EA. Shared clinical decision-making on vaccines: out of sight, out of mind. J Am Med Inform Assoc. 2021;28(11):2523-2525. doi:10.1093/jamia/ocab147

3. Gebhart F. Pharmacists Want More Time with Patients. Drug Topics. March 18, 2019. Accessed June 11, 2024. https://www.drugtopics.com/view/pharmacists-want-more-time-patients

4. Kempe A, Lindley MC, O’Leary ST, et al. Shared clinical decision-making recommendations for adult immunization: what do physicians think? J Gen Intern Med. 2021;36(8):2283-2291. doi:10.1007/s11606-020-06454-z

5. Report Demonstrates that Pharmacist-Administered Vaccinations Have Increased Since the Onset of the Covid-19 Pandemic. News release. Global Healthy Living Foundation. January 18, 2023. Accessed June 11, 2024. https://www.businesswire.com/news/home/20230117005853/en

6. Maples JM, Zite NB, Oyedeji O, et al. Availability of the HPV vaccine in regional pharmacies and provider perceptions regarding HPV vaccination in the pharmacy setting. Vaccines (Basel). 2022;10(3):351. doi:10.3390/vaccines10030351

7. Berenbrok LA, Gabriel N, Coley KC, Hernandez I. Evaluation of frequency of encounters with primary care physicians vs visits to community pharmacies among Medicare beneficiaries. JAMA Netw Open. 2020;3(7):e209132. doi:10.1001/jamanetworkopen.2020.9132

8. Gallagher A. Pharmacist-Administered Vaccinations Show Increase Since Onset of COVID-19 Pandemic. Pharmacy Times. January 24, 2023. Accessed June 11, 2024. https://www.pharmacytimes.com/view/pharmacist-administered-vaccinations-show-increase-since-onset-of-covid-19-pandemic

9. How Convenient Are Pharmacies to Most US Residents? US Pharmacist. August 31, 2022. Accessed June 11, 2024. https://www.uspharmacist.com/article/how-convenient-are-pharmacies-to-most-us-residents

10. Pharmacist Administered Vaccines. National Alliance of State Pharmacy Associations. Updated April 2023. Accessed June 11, 2024. https://naspa.us/wp-content/uploads/2021/01/Pharmacist-Immunization-Authority-April-2023.pdf

11. Protheroe J. Health literacy: a necessity for increasing participation in health care. Br J Gen Pract. 2009;59(567):721-723. doi:10.3399/bjgp09X472584

12. Lorini C, Santomauro F, Donzellini M, et al. Health literacy and vaccination: a systematic review. Hum Vaccin Immunother. 2018;14(2):478-488. doi:10.1080/21645515.2017.1392423

13. Pharmacist Prescribing: Hormonal Contraceptives. National Alliance of State Pharmacy Associations. September 1, 2022. Accessed June 11, 2024. https://naspa.us/blog/resource/contraceptives/

14. Pharmacist-Initiated PrEP and PEP. National Alliance of State & Territorial AIDS Directors. 2021. Accessed June 11, 2024. https://nastad.org/sites/default/files/2021-11/PDF-Pharmacist-Initiated-PrEP-PEP.pdf