Standard of Care FAQ

1. Is the act expressly prohibited in statute or rules?
2. Is the act consistent with their education, training, and experience?
3. Is the act within the accepted standard of care that would be provided in a similar setting by a reasonable and prudent licensee or registrant with similar education, training, and experience?

1. Therapeutic Substitution: Under the amended Iowa Pharmacy Practice Act, pharmacists can exercise professional judgment in providing therapeutic substitutions, adhering to appropriate standards of care. This process involves thorough patient consultations to obtain informed consent before implementing changes; establishing protocols for notifying prescribers or primary care providers about substitutions or significant interventions; and maintaining robust documentation of all clinical decisions, interventions, and patient interactions within the pharmacy management system. These interconnected steps ensure safe, effective, and well-communicated therapeutic substitutions that prioritize patient care and interprofessional collaboration. Below is an example of therapeutic substitution in practice:

1. Reviews the patient's medical history and current medications.
2. Consults with the patient, explaining that Crestor is in the same drug class as Lipitor and may be equally effective for their condition.
3. Discusses potential benefits (lower cost) and any differences in side effects.
4. Obtains and documents the patient's informed consent for the substitution.
5. Dispenses Crestor 20mg (equivalent dose) instead of Lipitor 40mg.
6. Documents the substitution, including rationale and patient consent, in the pharmacy system.
7. Notifies the prescriber of the therapeutic substitution via fax or electronic communication.
8. Schedules a follow-up with the patient to assess the effectiveness of the new medication.

1. Make legal decisions more certain
2. Apply laws consistently
3. Reduce the need for interpretation

1. Reduced paperwork: Pharmacies may be able to discontinue some administrative procedures related to documenting specific tasks that were previously tightly regulated. Ultimately, pharmacies will still need to justify the activities of staff so determination will need to be made by the pharmacist/pharmacy on the documentation that is needed to support staff activities in the case of an investigation.
2. Elimination of "bright line" restrictions: The new framework removes much of the previous "bright line" language that explicitly detailed what certified technicians could or could not do.
3. Discontinuation of frequent regulatory updates: Pharmacies will still need to update their policies procedures when there is a change in pharmacy technology or practice.
4. Removal of PIC application process: Pharmacies will no longer need to go through an application and fee process for Pharmacist in Charge (PIC) changes, although pharmacies still need to report PIC changes to the Board of Pharmacy.
5. Cessation of seeking specific permissions: Pharmacies and pharmacists may be able to stop the practice of seeking explicit permission from legislators or regulators for each new service or technology they want to implement, if it falls within the standard of care and the pharmacist’s education, training and experience.
6. Discontinuation of rigid task delegation: Pharmacies can stop following strict guidelines on task delegation and instead use professional judgment to assign duties based on individual competence and the standard of care, within the scope of practice. Delegation is limited to non-clinical, technical, or nontechnical functions.

1. Specific task lists for pharmacy technicians
2. Rigid guidelines for task delegation in pharmacies
3. Detailed restrictions on pharmacist duties
4. Collaborative practice agreement requirements
5. Statewide protocols that can be approved by the BOP and state Medical Director

1. Prohibition on clinical decision-making by pharmacy technicians
2. Requirement for pharmacists to exercise professional judgment within their education, training, and experience
3. Necessity for proper documentation of clinical decisions and interventions
4. For noninstitutionalized patients, obligation to notify prescribers of therapeutic substitution within three business days following dispensing
5. Requirement to obtain informed consent from patients for therapeutic substitutions
6. Compounding (481 IAC—Chapter 552.22(155A))
7. Controlled substances (481 IAC—Chapter 553)
8. Immunization statewide protocols – to avoid opposition from anti-vaccine lobbyists, the portion of IC 155A detailing immunization statewide protocols remains unchanged.

1. Is the practice expressly prohibited by Iowa Code 155A or any other statute?
2. Is the practice expressly prohibited by the Board of Pharmacy rules or any other regulation?
3. Is the practice consistent with the education, training, and experience of the pharmacist and within the accepted standard of care that would be provided in a similar setting by a reasonable and prudent pharmacist with similar education, training, and experience?

1. Review Current Operations:
   • Conduct a thorough review of existing practices and procedures.
   • Identify areas that may need modification to align with the new regulatory model.
2. Audit and Update SOPs:
   • Ensure Standard Operating Procedures (SOPs) exist for all key processes.
   • Update existing SOPs to reflect changes introduced by HF 555.
   • Develop new SOPs for any additional services or practices that will be implemented.

1. Patient Assessment: Review the patient's medical history, current medications, and any relevant clinical information.
2. Evaluation of Therapeutic Equivalence: Determine if the proposed substitution is therapeutically equivalent and appropriate for the patient's condition.
3. Patient Consultation: Engage in a comprehensive discussion with the patient, explaining the rationale for the substitution, potential benefits, and any differences in side effects or administration.
4. Informed Consent: Obtain and document the patient's informed consent for the therapeutic substitution.
5. Documentation: Record the decision-making process, including the rationale for substitution, in the pharmacy management system.
6. Prescriber Notification: Establish a protocol for promptly notifying the prescriber or primary care provider about the therapeutic substitution, including details of the change and the rationale. Template for notification should provide the directive of how to notify the provider (call, fax, etc.) and should clarify that the notification is required within three business days.
7. Follow-up: Schedule a follow-up with the patient to assess the effectiveness of the new medication and address any concerns.

3. Subscribe to Information Resources:

• Maintain a subscription to the Iowa Pharmacy Association's Law & Information Resource Center (LIRC) [LINK].
• Review the Standard of Care resources found on the Iowa Pharmacy Association website. [LINK]

4. Update Job Descriptions:
   • Revise job descriptions for all pharmacy staff to reflect new responsibilities and expectations under the standard of care model.
   • For Pharmacists:
     • Emphasize clinical decision-making skills and patient consultation abilities.
     • Include responsibilities related to therapeutic substitution and medication therapy management.
     • Highlight the importance of staying current with continuing education and professional development.
   • For Pharmacy Technicians:
     • Clarify the scope of technical tasks that can be performed under pharmacist supervision.
     • Emphasize the importance of accuracy and attention to detail in supporting pharmacists' expanded roles.
     • Include responsibilities related to maintaining and updating patient records.
   • For Pharmacy Interns:
     • Outline learning objectives that align with the new practice model.
     • Include graduated responsibilities that prepare interns for future pharmacist roles under the new regulations.
5. Implement Training Programs:
   • Develop and conduct training sessions on new procedures and responsibilities.
   • Ensure all staff members understand the implications of the standard of care model on their daily practices.
6. Establish Quality Assurance Measures:
   • Implement systems to monitor and evaluate the quality of care provided under the new model.
   • Develop metrics to assess adherence to the standard of care and identify areas for improvement.
7. Enhance Documentation Practices:
   • Implement robust documentation systems that capture all clinical decisions and interventions.
   • Ensure all staff members are trained in proper documentation techniques to support the standard of care model.
8. Foster a Culture of Continuous Improvement:
   • Encourage open communication about challenges and opportunities in implementing the new model.
   • Regularly review and update practices based on feedback and emerging best practices.

• Chapter 550: Definitions
• Chapter 551: Licenses, Registrations, and Permits
• Chapter 552: Standards – Practice of Pharmacy
• Chapter 553: Controlled and Precursor Substances
• Chapter 554: Operational Standards – Distribution and Drug Supply Chain
• Chapter 555: Standards – Drugs in EMS Programs
• Chapter 556: Iowa Prescription Monitoring Program
• Chapter 557: Board of Pharmacy Operations

1. Continue to follow current regulations under IAC 657
2. Stay informed about proposed rule changes
3. Participate in public comment periods when available
4. Begin preparing for the implementation of the new standard of care model
5. Engage in ongoing education and training to align with anticipated changes

• Scope of practice: What you MAY do legally and under regulations
• Clinical ability: What you CAN do or are capable of doing based on your training and skillset
• Scope of practice applies to a profession, while clinical ability varies from individual to individual

Q23: What are some key changes introduced by HF 555?
A23: Some key changes include:

• Expanded authority for pharmacists to engage in therapeutic substitution
• Introduction of statewide protocols for pharmacists to order and administer certain drugs, products, tests, or treatments

• Dispense, administer, monitor, and issue prescription drugs, biological products, and medication orders commensurate with their training and education
• Engage in therapeutic substitution (with some restrictions)
• Order and administer certain prescription drugs, products, tests, or treatments under statewide protocols