Do Federal and State Regulations Create Barriers to Community Pharmacy Practice Expansions?

Research on the correlation between the expansion of community pharmacy practice as a broader pathway into primary care is limited. Although consumers envision a new pharmacy health care model to expand primary care services with physician-pharmacist collaboration, expanding community practices can contribute to this new model. Considering specific legal and regulatory barriers that contribute to limited accessibility, it is essential to understand how to eliminate them to make pharmacy practices more accessible. Walgreens is already addressing prescription filling pressure by building multiple central fill centers around the US near Walgreens–Village Medical primary care clinics.¹ Walgreens estimates that these automated hubs can fill nearly half of its prescription volume. To further explore the barriers surrounding community pharmacy practices and prescription accessibility, one must understand all of the barriers US patients face today.

Pharmacies should review 6 barriers and, if applicable, investigate the restraint of community pharmacy practice expansion across the US, state by state. Barriers include collaborative practice agreements and pharmacy scope of practice; remote processing and working from home; central fill pharmacy services; technician ratio and supervision; telepharmacy; and therapeutic interchange. Understanding these barriers can help pharmacists continue to provide improvements in primary care.

Collaborative Practice Agreements and Pharmacist Scope of Practice

Collaborative practice agreements exist across all states but vary across three divergent areas. Some agreements are population specific and some patient specific. The latter has barriers that force the need for an established patient-specific relationship for both the provider and the pharmacist. No current data exists either verifying the need for these regulations or proving that they are obstructions for patients or providers, so work should be undertaken to verify that these regulations provide a greater safety net for patients. The second barrier is the type of provider approval that is allowed. If the provider is in good standing in the state, why is the specialty of the provider necessary to provide quality patient care? The third barrier is the need for additional pharmacist training or educational requirements, limitations on practice settings, and/or specific requirements for liability coverage. The development of consistent collaborative practice agreements across the US is necessary to expand community pharmacy practice.

Remote Processing and Working from Home

Shared services, including data and clinical reviews by pharmacists and data entry by pharmacy technicians, are essential processes that allow pharmacists to provide time for greater clinical activities. The ability to monitor a pharmacy technician’s duties by video/communication technology with appropriate privacy and security standards allows greater time for pharmacists to participate in expanded practice roles. However, the most controversial issue is the ability of nonresident pharmacists to oversee central fill sites. In many states, pharmacy personnel must be registered in their home and remote practice states. The National Association of Boards of Pharmacy (NABP) should develop policies and procedures to account for these scenarios. For example, the NABP Verify program allows nonresident pharmacists to practice where barriers are reduced or eliminated.

Central Fill Services

Central fill pharmacy services are critical to providing time for pharmacists to participate in clinical activities. However, there are several barriers when trying to implement this service. First, product verification by a pharmacist at the start and finish of the automation process proves difficult. The best-trained data entry operator will make an error approximately every 300 keystrokes, whereas barcode technology has an error rate of <1 error in 394,000 scans.² Given this data, it would seem logical to allow this technology to be used in central fill service locations. In addition, the robustness of the error rate demonstrates that the requirement of a final recheck is not necessary for this type of dispensing. The distance between the primary pharmacy and the central fill locations is also restricted in some states. For example, some states only allow pharmacists to perform work for citizens of that state while others only allow the originating pharmacy to be in-state. Who suffers from these restrictions—border communities and the underserved and rural communities. In addition, labeling requirements are also an issue in several states, and simplifying them would seem to be a logical step.

Technician Ratio and Supervision

Another critical issue is technician ratios, mainly because these ratios differ across states. To alleviate the burden on pharmacists, the NABP could establish a one-size-fits-all technician ratio to reduce the requirements they must consider. It is difficult to understand why one state allows unlimited technicians to practice under one pharmacist while other states have restrictions on the ratio. Finally, several states limit the ability for pharmacy personnel to work from home. Why? The COVID-19 pandemic taught us that working from home can be safely accomplished across many job titles, including pharmacy.

Telepharmacy

Telepharmacy can be defined as a form of “pharmaceutical care”³ where patient interactions transpire via information technology facilities. Implementation barriers for this service include the use of these facilities to observe pharmacy technician responsibilities, milage restrictions between the nearest pharmacy and to the telepharmacy location, patient and supervisory consultations, and extensive technology requirements. Less restrictive telepharmacy policies showed fewer pharmacy deserts.⁴ To reduce telepharmacy barriers, the NABP could establish standardization across state statutes and regulations.

Therapeutic Interchange

Perhaps the most controversial of all the 6 barriers is therapeutic interchange (TIC). TIC is defined as “the act of switching a prescribed drug for another drug in the same therapeutic class that is believed to be therapeutically similar but may be chemically different.”⁵ TIC is not a new subject, having become common practice in 80% of hospitals since 2002.^5,6 Approximately 9 states include some form of TIC. Pharmacists in most states must contact the prescriber and request a new prescription, often for minimal changes in the therapeutic benefit-to-risk ratio. Obviously, this delays patient care, adding unnecessary administrative burden to the health care system. The development of a national TIC list would be most welcome for the system to function in a manner that benefits all parties. These 6 barrier are in place for all new pharmacy practice expansions. Coming together as a profession to discuss these areas, find common ground, and implement solutions across legislative and regulatory bodies would benefit our patients.

References

1. Repko M. Walgreens turns to robots to fill prescriptions, as pharmacists take on more responsibility. CNBC. Published March 30, 2022. https://www.cnbc.com/2022/03/30/walgreens-turns-to-robots-to-fill-prescriptions-as-pharmacists-take-on-more-responsibilities.html. Accessed September 14, 2023.
2. Barcode Reading and Accuracy – mLabCE.com, Laboratory Continuing Education. www.labce.com. https://www.labce.com/spg650115_barcode_reading_and_accuracy. Accessed September 14, 2023.
3. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990;47(3):533-543. https://pubmed.ncbi.nlm.nih.gov/2316538/
4. Urick BY, Adams JK, Bruce MR. State telepharmacy policies and pharmacy deserts. JAMA New Open. 2023;6(8):e2328810. doi:10.1001/jamanetworkopen.2023.28810.
5. Vanderholm T, Klepser D, Adams AJ. State approaches to therapeutic interchange in community pharmacy settings: legislative and regulatory authority. J Manag Care Spec Pharm. 2018;24(12):1260-1263. doi:10.18553/jmcp.2018.24.12.1260.
6. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing—2016. Am J Health Syst Pharm. 2017;74(17):1336-52. doi:10.2146/ajhp170228