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Standard of Care Regulatory Model

What is it?

A standard of care regulatory model evaluates pharmacist practice based on whether the care provided is consistent with what a prudent and reasonable pharmacist with similar education, training, and experience in a similar practice setting would do under similar circumstances. Rather than enumerating every permitted activity in statute or regulation, this model relies on professional judgment and standards of practice, with accountability enforced through professional discipline when care falls below acceptable standards.

The push towards a standard of care regulatory model is dedicated to helping modernize the regulation of pharmacy practice to ensure that pharmacists are held to the same standards as other healthcare providers to ensure optimal patient safety and outcomes.

Questions about SOC? Contact Us

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Kyle Bryan CAPP Director of Professional Affairs

Email
kyle.bryan@uky.edu

Frequently Asked Questions

A SOC regulatory model offers KY a pathway to modernize pharmacy regulation while maintaining strong public protections. It does not eliminate oversight or replace legislative authority over scope of practice. Rather, it provides a flexible accountability-driven framework that allows pharmacists to fully contribute to patient care today while remaining adaptable to the needs of tomorrow.

Isn't standard of care just a fancy phrase for deregulation?

Standard of care regulation does not eliminate oversight, nor does it grant unlimited authority to all pharmacists. It does not replace professional accountability or permit pharmacists to practice beyond their competence. Instead, it places greater emphasis on professional judgment, individualized competence, and outcome-based oversight. Statutes and regulations remain in place to guide practice while allowing for professional judgment to ensure patients receive the best possible care based on the latest standards.

Is standard of care an expansion of scope?

Standard of care regulation is not an expansion of the scope of practice and does not allow for full practice authority. Full practice authority defines the scope of services pharmacists are legally permitted to provide (e.g., protocol-driven care, ordering labs, administering medications). Standard of care defines how those services are regulated and evaluated once they are within scope. A standard of care model does not automatically expand scope, but rather allows scope to be exercised with more flexibility and direct provider responsibility without constant regulatory and statutory revision.

How is this different than how practice is currently regulated?

Kentucky primarily regulates pharmacy practice through a prescriptive, rule-based framework that strictly outlines what a pharmacist can and cannot do based on the capabilities of the least qualified individual imagined by the Board of Pharmacy. This model treats all providers the same and does not take into account the varying levels of training, experience, and competency held by different pharmacists.

What are the benefits of the standard of care model?

  • Improved Patient Access: A SOC framework would eliminate unnecessary administrative burden that limits the implementation of advanced care services that are needed to address the primary care physician shortage in the state
  • Improved Patient Care: A SOC framework holds practice to actual competence rather than minimum statutory permissions, while allowing pharmacists to respond more quickly to patient needs without waiting for service-specific regulatory changes to update to match best practice standards
  • Alignment with Education and Training: Kentucky pharmacists are highly trained and educated. A SOC framework allows pharmacists to utilize their professional judgment and clinical knowledge to provide the best possible care rather than minimum regulatory permissions
  • Reduced Regulatory Lag: As new therapies, diagnostics, and care models emerge, SOC regulation allows adoption based on evidence and professional norms rather than delayed rulemaking from a limited number of government officials
  • Regulatory Efficiency: Boards of pharmacy can focus on patient safety and outcomes rather than maintaining and updating extensive lists of permitted acts
  • Consistency with other health professions: Medicine and nursing in KY already rely on SOC frameworks, making SOC a familiar and credible regulatory approach