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Standard of Care FAQ

Jump to: General Questions | Therapeutic Substitution | Pharmacy Technicians | Pharmacy Operations | Compliance

IPA has compiled questions from pharmacy professionals regarding the updated Iowa Pharmacy Practice Act and standard of care regulatory framework. IPA has answered these questions with input from staff, members, and national pharmacy experts.  

IPA continues to update this FAQ resource. Please submit your questions to rmcclellan@iarx.org.  

**The following responses are not intended to be legal advice. To search this page by keyword, press CTRL + F.


GENERAL QUESTIONS 

Q: How will HF 555 be referenced once it goes into effect?
  • Iowa Pharmacy Practice Act
  • Iowa Code 155A (IC 155A)  
Q: What changes are allowed July 1, 2024 in terms of SOC practice?
  • Everything in HF 555.
  • Pharmacists should be cognizant of what current practice allows and what the Board of Pharmacy might recognize as pushing the limit. What is appropriate to do when you engage, i.e., therapeutic substitution: having a consultation with the patient and getting their consent on the practice; notifying the prescriber after you do make any changes; recording that process and making sure it is documented somewhere within your system. Think through the process of what is appropriate and what you should have on hand.
  • The Board of Pharmacy is also working through this change and will have to safely regulate.
Q: How do we best prepare for practicing under a standard of care regulatory model?
  • Use current operations as a starting point and audit current businesses to ensure SOPs and processes exist.
  • Subscribe to the Iowa Pharmacy Association’s Law & Information Resource Center (LIRC)
Q: Does HF 555 require payment for pharmacist services?
  • No. 
Q: How does the Pharmacy Practice Act relate to Board of Pharmacy rules?
  • The Iowa Pharmacy Practice Act serves as legislation that adds certain subsections to existing sections of the Iowa Administrative Code (IAC) that the Board of Pharmacy (BOP) enforces, along with removing certain provisions of the existing IAC that were burdensome to the BOP administration and/or efficiency of pharmacy practice. 

Q: What is the difference between standard of care and standard of practice?   

  • Scope of practice is the services that a qualified healthcare professional is deemed competent to perform and permitted to undertake in keeping with the terms of their professional licensure.
  • Scope of practice (what you MAY do, what legally and under regulation you're allowed to do) vs. clinical ability (what you CAN or are capable of doing, what you’re trained to do, or what is in your skillset).
  • Scope of practice is one size fits all. Clinical ability varies from individual to individual.


THERAPEUTIC SUBSTITUTION 

Q: What considerations do pharmacists need to take into account? 

  • It is best practice to consult with the patient prior to making substitutions and notify the prescriber/PCP afterwards.

Q: Does the therapeutic substitution aspect of the legislation apply to biosimilars?

  • Yes, it is broadly written to include biosimilars on Page 2 of HF 555. The subsection added to Section 155A.3 covers this and specifically includes “biological product” in the alternative drug or device that may be substituted.

Q: Can we therapeutic substitute different extended-release potassium capsules vs. tablets?

  • Yes, replacement of a prescribed drug with an alternative formulation with assumed equivalent therapeutic effect is covered under Section 155A.3, Subsection 49A.


PHARMACY TECHNICIANS

Q: How will these changes affect pharmacy technicians?

  • Pharmacy technicians are regulated under the same standard of care regulatory framework.  

Q: Can a certified pharmacy technician working in the clinical setting transmit medication refills to a pharmacy as a prescriber’s authorized agent?

  • If the pharmacy technician is trained and educated to do so, it may be appropriate if the technician has the agency and relationship with the pharmacist, and the pharmacist is comfortable with delegating these duties to the technician.


PHARMACY OPERATIONS

​Q: Does the Pharmacist in Charge (PIC) role remain?

  • The PIC role will still be required; however, there will no longer be an application and fee associated with PIC updates. PIC changes will still need to be reported to the Board of Pharmacy.

Q: With no PIC listed on registration, do we need to spell out the duties to individuals in policies, or can we still refer to the term “PIC” within our policies if we title someone PIC?

  • You can continue to use the verbiage of “PIC.” The PIC designation is a regulatory practice by the Board of Pharmacy to make sure there is a responsible party for certain policies and procedures in the pharmacy. It is best practice to make sure that PIC responsibilities and duties are allocated to someone. You could delegate those duties across multiple individuals (pharmacists or technicians). If you want to delegate everything to one person, that is also permissible. It would be best to outline who is responsible within your policies and procedures.


COMPLIANCE

Q: Are the current 657 rules still in place?

  • Yes, the 657 rules are still in effect until new rules are adopted and made effective by the Board of Pharmacy. 

Q: What happens if a compliance officer doesn't agree with something we do, even if a large group of reasonably competent pharmacists agree? Could it still come down to the opinion of a few?

  • The Board of Pharmacy will identify experts and ultimately make the decision. They will use resources from experts in the field, as well as standards across the country and state of Iowa that have been written by professional associations and other healthcare organizations to make the determination if something was or was not appropriate. It will not be down to the decision of one person. There is still a process to determine if something was appropriate. 

Q: How do I decide if I can do something under the new framework?

  • Questions to consider include: 1) Are you trained and educated to do it? 2) Is the practice being done in other states or other sites in Iowa?