Standard of Care: The Number 1 Priority to Ensure Success in Pharmacy Practice’s Future

What is Standard of Care and Why is it Critical?

The standard of care (SOC) in health care regulation and law refers to the expected level of practice provided by a reasonable and prudent professional with similar qualifications in a similar situation.^1-4 Rather than adhering to detailed, prescriptive rules specifying exactly how health care should be delivered, SOC emphasizes adaptability and individual professional judgment without compromising quality as individuals are held to the standard and expertise of their practice area. Under this model, pharmacists can have the opportunity to practice with independent authority based on their education, training, and clinical experience, provided they align their decisions with widely accepted professional standards and guidelines.

SOC emphasizes adaptability | Image credit: MrPanya | stock.adobe.com

One misconception is that SOC means full practice authority, which is not entirely true. After adopting SOC, to move towards full practice authority it is critical do conduct a full rule rewrite and clean up pharmacy practice acts.^1-4 To truly achieve full practice authority, having a SOC enforcement regulatory framework is necessary, as is removing unnecessary laws and rules. For a visual example, think of SOC as the key and full practice authority as the lock; both are crucial to unlock full potential.

Idaho provides an illustrative example of SOC, in which pharmacists have full authority to independently prescribe medications, administer vaccines, order and interpret lab tests, and adapt prescriptions.^1-4 For instance, Idaho pharmacists may independently prescribe treatments for minor ailments like influenza or urinary tract infections without detailed regulatory constraints. Since they have adopted proper SOC framework within their laws and rules, pharmacists who partake in decision making must reflect the standard of practice among peers with comparable education and training. In instances where safety is compromised or negligence is exhibited via subject matter experts, pharmacists are held to this standard by the board of pharmacy.⁵

For years, associations, stakeholders, and states have advocated for fragmented bits and pieces of expanding practice authority.⁶ Prime examples of this are bills for narrow services focused on specific areas such as hormonal contraceptives, naloxone, and immunizations, amongst many others.⁷ While historically these incremental moves may seem like a win to associations and others, it has paved an inefficient and bureaucratically challenging scenario towards full practice authority. The more categories and fragmented areas added to laws and rules, the more challenging and unlikely it becomes for state boards of pharmacy and legislatures to make common sense and timely updates. This cripples the profession and ensures laws and rules will always be behind standards of practice and future practice models.

Standard of Care vs. Bright Line Rules

In contrast to the standard of care model, bright line rules—also known as prescriptive or rule-based regulations—provide rigid and explicit language. This regulatory approach clearly defines allowable practices, leaving little room for professional discretion or adaptation to specific circumstances. It also opens the door for a punitive culture of enforcement, citations, and discipline by state agencies based on laws and rules that may or may not be backed by evidence or a burden of proof of patient safety. This current, prescriptive system is outdated, unfair to pharmacy staff, limits access to care, and holds the profession back as a whole.

Bright line rules are straightforward and predictable but tend to restrict innovation and prevent pharmacists from fully utilizing their clinical expertise. For example, under bright line regulation, pharmacists must seek permission before expanding services, such as prescribing new vaccines or medications. Conversely, under SOC, pharmacists may implement such expansions if supported by current clinical evidence and professional judgment.^1-5

SOC models offer adaptability and encourage professional autonomy, which supports rapid innovation and improved access to patient care. This flexibility contrasts sharply with bright line regulation, which often lags behind advancements and can create unnecessary barriers to patient access and pharmacist utilization.

Pharmacy vs. Nursing and Medicine: Enforcement Styles and Differences

Historically, pharmacy regulation has been highly prescriptive and detailed, with significantly higher regulatory burdens compared to medicine and nursing. Pharmacy laws frequently specify minute operational details such as facility requirements, font sizes on labels, running water requirements, prescription handling protocols, documentation, and more, far exceeding the regulatory complexity or burden in medicine or nursing.

In a comparative analysis, Idaho’s pharmacy regulations had approximately twice the word count of medical or nursing regulations, highlighting pharmacy’s restrictive, detail-oriented approach.⁴ Another analysis of word counts of laws and rules across all 50 states and the District of Columbia on language relating to administration of immunizations showcased a drastic difference further isolating pharmacy compared to medicine and nursing.⁸ Medicine and nursing professions traditionally operate under a SOC framework, enabling these professions to evolve rapidly with medical advancements without constant regulatory updates or shackles. They key point is to truly move to SOC; state rules need to be eliminated, and practice act laws placed in alignment.^1-4

Idaho’s shift to SOC demonstrates that pharmacy can successfully adopt regulatory flexibility seen in medicine and nursing.^1-4 This approach better aligns pharmacists’ practice authority with their comprehensive clinical training, promoting patient-centered, adaptive care.

States Moving Toward Standard of Care in Pharmacy

Idaho pioneered the SOC approach in 2017, significantly reducing pharmacy regulatory burdens and promoting innovative practices.^1-4 Following Idaho’s successful transition, Alaska and Iowa have worked toward SOC regulation, signaling a growing national trend. Iowa, notably, is in the process of removing over 36,000 words of prescriptive regulation, cutting more than 40 chapters of rules to just 8, emphasizing flexibility and pharmacist autonomy.⁹

These states adopted clear frameworks outlining that pharmacists may engage in any patient-care activity not explicitly prohibited by law, provided their actions align with professional standards. The National Association of Boards of Pharmacy and American Pharmacists Association endorse the SOC approach, encouraging further adoption across the country.^3,10

The Way Forward: Unlocking Full Practice Authority through Standard of Care

Transitioning pharmacy practice nationwide toward the SOC model can significantly improve health care accessibility and patient outcomes. Actions states and pharmacy stakeholders can take include the following:

• Adopt broad definitions of pharmacy practice: Define pharmacy practice broadly in law and rule, enabling pharmacists to adapt to new clinical practices and technologies without needing constant legislative or regulatory updates.
• Eliminate unnecessary prescriptive regulations: Identify and remove regulations that unnecessarily restrict professional judgment, focusing regulatory oversight on patient outcomes rather than process adherence.
• Define SOC to enhance pharmacist autonomy and accountability: Clearly define SOC in law, emphasizing pharmacist responsibility for clinical outcomes and decision-making. Utilize model language from states such as Idaho, Iowa, or Alaska.
• Move away from incremental fragmented advocacy efforts: State associations, stakeholders, and others should move away from passing bills on singular categories of prescribing or services and instead focus on SOC and full practice authority in tandem.
• Implement clear delegation frameworks: Allow pharmacists to delegate appropriate tasks to qualified technicians or support staff based on professional judgment rather than regulatory constraints.
• Advocate and educate policymakers: Pharmacists must actively advocate for SOC regulation, educating lawmakers and regulatory bodies on its benefits in reducing health care costs, expanding patient access, and fully utilizing pharmacist training and expertise. Push back on state agencies who want to continue down a broken and punitive disciplinary pathway to preserve their incentives.

By embracing SOC and full practice authority in tandem, pharmacy practice can move away from restrictive frameworks toward a dynamic model that supports professional judgment, innovation, and expanded patient care opportunities. This regulatory evolution represents a crucial step toward unlocking pharmacists’ full clinical capabilities, ultimately enhancing health care quality and accessibility nationwide.

REFERENCES

1. Adams JL, O’Connor S, Seignemartin B, et al. Battling professional self-sabotage: embracing standard of care as the future of pharmacy regulation. J Am Pharm Assoc. 2023;63(6):1685-1688. doi:10.1016/j.japh.2023.08.015

2. Frost T, Wolfson J. Toward Pharmacist Full Practice Authority. Cicero Institute. November 6, 2024. Accessed April 14, 2025. https://ciceroinstitute.org/research/toward-pharmacist-full-practice-authority/

3. Adams AJ, Chopski NL, Adams JA. How to implement a “standard of care” regulatory model for pharmacists. J Am Pharm Assoc. 2024;64(3):102034. doi:10.1016/j.japh.2024.02.007

4. Adams AJ. Transitioning pharmacy to “standard of care” regulation: analyzing how pharmacy regulates relative to medicine and nursing. 2019:15(10):1230-1235. doi:10.1016/j.sapharm.2018.10.008

5. Adams AJ, Chopski NL. Rethinking pharmacy regulation: core elements of Idaho’s transition to a “standard of care” approach. J Am Pharm Assoc. 2020;60(6):E109-E112. doi:10.1016/j.japh.2020.07.013

6. Eid D. Full scope of pharmacy practice: reinventing the future and overcoming barriers. Pharmacy Times. February 19, 2024. Accessed April 14, 2025. https://www.pharmacytimes.com/view/full-scope-of-pharmacy-practice-reinventing-the-future-and-overcoming-barriers

7. Adams AJ, Eid DD. Toward collaborative practice, not collaborative practice agreements. Am J Health-Syst Pharm. 2024;81(7):e157-e158. doi:10.1093/ajhp/zxad280

8. Eid, D. D., Bailey, N., Hendricks, M., & Li, J. (2021). Standard of care: A national three profession survey of healthcare state agencies. Ferris State University College of Pharmacy Poster Presentation at NABP Annual meeting.

9. Rulemaking Published. Iowa Department of Inspections, Appeals, and Licensing. August 8, 2024. Accessed April 14, 2025. https://dial.iowa.gov/rulemaking/2024-08-08/rulemaking-published

10. Report of the Task Force to Develop Regulations Based on Standards of Care. National Associations of Boards of Pharmacy. December 2018. Accessed April 14, 2025. https://nabp.pharmacy/wp-content/uploads/2018/12/Task-Force-to-Develop-Regulations-Based-on-Standards-of-Care-December-2018-1.pdf