STANDARD OF CARE REGULATORY MODEL

Rationale

Standard of care regulatory models for pharmacy practice (e.g., pharmacist-provided clinical care, patient safety, automation, compounding standards) allow pharmacists to operate with greater autonomy and use their professional judgment and expertise within a defined scope of practice. States with existing standard of care regulatory models include: Idaho (implemented in 2018), Alaska (transitioned to through rulemaking in 2023), Montana (passed a bill in 2023), and Iowa (adopted via legislative reform in 2024). The federal pharmacy services (e.g., Veterans Affairs, Department of Defense, Public Health Service) operate under a standard of care framework and credential and privilege pharmacists using a defined scope of practice.

As regulation of pharmacy practice has become more complex, there is a growing interest in adopting a standard of care regulatory model, which has the potential to remove a significant volume of detailed rules. Today, many states have complex rules dictating exactly which test, therapy, or disease state intervention pharmacists can provide. Each new statutory allowance introduced into pharmacy practice often necessitates the development of corresponding competencies or implementation of training courses. Much like physicians, nurses, and other healthcare professionals, pharmacists should instead be held to the standard of care rather than relying on ‘brightline’ rules or standards, which leave little room for interpretation. The standard of care model allows practice to align with the highest level of education and training for that individual.

Like physicians, privileging and credentialing will help to determine the appropriate education and training associated with the scope of practice required for the setting. ASHP encourages health systems to incorporate pharmacists into established privileging programs that align with education, training, and practice experience in their designated setting(s) (see ASHP policy 1415, Credentialing, Privileging, and Competency Assessment). Within many health-systems, pharmacists have been integrated into their privileging processes but adoption of standard of care regulatory models will require revised privileging procedures and pharmacists’ inclusion in healthcare insurance credentialing procedures to support reimbursement. ASHP advocates for the inclusion of pharmacists in health insurance credentialing processes consistent with their authorized scope of practice (see ASHP policies 2011, Credentialing and Privileging by Regulators, Payers, and Providers of Collaborative Practice; and 2405, Pharmacist Access to Provider Networks).