Week 6: ACS (Patterson + Bilek)

Organization of Chapter 151

definitions → board → people → places → conduct → special programs

Major Sections of Chapter 151

151.01: definitions

151.02-.06: Board/powers; 151.065: fees

151.07-.13: pharmacists; 151.101: interns; 151.102: technicians

151.15/.19: pharmacies

151.21/.211/.34-.36: conduct

151.37+: special regimes/programs

What is the main purpose of the statute sections dealing with special programs/authorities?

they establish specific legal authority for activities beyond the basic pharmacy framework

What is the relationship between Chapter 151 and Chapter 6800?

Chapter 151 = legislative authority

Chapter 6800 = Board rules operationalizing that authority

Organization of Chapter 6800

definitions → pharmacy/core standards → people → operations/processes → special settings

Major Sections of Chapter 6800

6800.0100: definitions

.0200-.1100: pharmacy licensing/core practice standards

1150-.1600: pharmacist licensing/CE

.2150-.4075: operations/processes

.7100-.7950: hospital pharmacy

.8000-.8008+: special settings/programs

Where should you generally look for pharmacy operations/process rules?

middle of Chapter 6800, especially the 2000-4000 series

Where should you generally look for hospital-specific pharmacy rules?

7000 series

What is the key difference between statutes and rules?

statutes authorize; rules operationalize how pharmacy practice must occur

How does "conduct" differ between statutes and rules?

statutes focus more on professional conduct/discipline/authority; rules focus on how pharmacy processes are performed

What is the medication provision chain?

order → entry → compounding/dispensing → certification → labeling → counseling → records

What is the baseline requirement for an open pharmacy?

at least one pharmacist must be present and on duty

Can technicians enter the pharmacy before the pharmacist arrives?

No, when no pharmacist is on duty, pharmacy access is generally prohibited

What activities are generally confined to the pharmacy?

compounding, dispensing, receiving verbal orders, and selling drugs, except for specific legal exceptions

Can emergency prescription orders ever be handled outside a closed pharmacy?

Yes, but only under specific statutory conditions for qualifying facilities/emergencies

How should you think about hospital pharmacy rules compared with community rules?

they often answer the same legal questions, but with hospital-specific requirements

What four elements are required for after-hours nurse access to a hospital pharmacy?

written policy + designated nurse + limited quantity for immediate need + documentation/pharmacist review

How can a nurse legally obtain IV diltiazem when the hospital pharmacy is closed?

designated nurse follows the existing written policy, removes only what is immediately needed, documents it, and the pharmacist reviews it afterward

What must be documented for an after-hours medication removal?

what, how much, when, who removed it, and for whom

Why must the after-hours access policy exist BEFORE the emergency?

without a compliant preexisting policy, there is no legal pathway for the nurse to enter the pharmacy

Who may perform compounding and dispensing?

pharmacist, practitioner, or pharmacist intern under immediate/direct pharmacist supervision

Importance of Rule 6800.3100

it identifies the specific reserved acts involved in compounding and dispensing

What must a pharmacist do when certifying a prescription?

verify the label, drug, strength, dosage form, complete the DUR/profile review, and apply a unique identifier

What does certification legally mean?

you are attaching your license/professional responsibility to that dispensed product

What can qualify as a pharmacist's "unique identifier"?

manual, biometric, or Board-approved electronic identification

What must happen within 72 hours for a new prescription?

a pharmacist/intern must compare the original prescription with the information entered into the system

Can the certifying pharmacist immediately perform the QA check?

No, they cannot perform it within 2 hours of their certification

Why does the QA rule separate the check from certification?

to reduce confirmation bias and prevent data-entry errors from carrying into future refills

Why are USP

rule 6800.3300 adopts them by reference into Minnesota law

What is the proper delegation sequence for compounding?

pharmacist establishes/validates formulation record → technician compounds → pharmacist/intern certifies

Can a technician independently create a new formulation from a recipe?

No, the pharmacist must establish/validate the formulation record first

What two additional legal requirements apply to compounded preparations?

a governed beyond-use date (BUD) and a compliant compounded-product label

What is the big legal principle behind compounded-product labeling?

the product must maintain a traceable record of what was prepared, for whom, and under what conditions.

What happens legally whenever a drug changes container or hands?

rules generally require a record documenting that transformation

What should pharmacy records allow an inspector to trace?

a dose back to its person, process, and source

What does Minnesota require for a NEW prescription?

the pharmacist must personally initiate counseling

Does "Do you have any questions for the pharmacist?" satisfy the requirement?

No, that is only an offer to counsel, which is insufficient for a new prescription in Minnesota

Who must initiate the counseling discussion?

the pharmacist

What major areas must new-prescription counseling address?

drug/use, dose/administration/duration, precautions, adverse effects + what to do, monitoring, storage, refills, and missed doses

Is the counseling rule a complete clinical counseling script?

No, it is the legal minimum/floor; professional judgment may require more

What might trigger counseling on a refill?

new strength, interaction/DUR concern, adherence issue, unusual pickup timing, or patient confusion

Can a patient refuse counseling?

Yes, but the refusal must be documented

What happens if a new prescription requiring counseling is ready while the solo pharmacist is on break?

the patient must wait or receive a pharmacist callback; counseling still must occur

What can technicians do in the counseling process?

route/flag the patient or arrange logistics/callbacks, but never provide the pharmacist counseling themselves

Why can inpatient unit-dose labeling differ from outpatient vial labeling?

the system as a whole provides required information, and medications are generally administered by licensed personnel

What is centralized processing?

one pharmacy performs part of the dispensing workflow for another pharmacy, such as data entry or data-entry verification

What are the 4 main sources of law?

constitution, legislature, administrative agencies, and courts

What does each major source of law produce?

Legislature → statutes

Administrative agencies → rules/regulations

Courts → case/common law

What administrative agencies are most relevant to pharmacy practice?

FDA, DEA, and state Board of Pharmacy

What happens when federal and state law conflict?

federal law preempts state law

Can a state law be stricter than federal law?

Yes, a stricter state law can apply as long as it does not conflict with federal law

Where does federal authority to regulate drugs generally come from?

the Interstate Commerce Clause of the U.S. Constitution

What is the legislative function of an administrative agency?

to promulgate regulations/rules that interpret, define, and add detail to statutes

How are administrative regulations generally enacted?

through notice-and-comment rulemaking

What 3 requirements determine whether an administrative regulation is valid?

It must: be within the agency's authority, be based on statutory authority, reasonably relate to public health, safety, and welfare

What is the primary role of the Board of Pharmacy?

to protect public health, safety, and welfare, not to protect pharmacists

What is the judicial function of an administrative agency?

to conduct hearings and render decisions, such as pharmacist disciplinary decisions

Can an administrative agency's decision be reviewed by a court?

Yes, courts review whether the decision was supported by substantial evidence

How do criminal, civil, and administrative proceedings differ?

Criminal: government vs. private party → deter/punish/rehabilitate

Civil: usually private vs. private → compensate injured party

Administrative: agency vs. private party → professional discipline

What consequences can result from an administrative proceeding against a pharmacist?

warning/reprimand, fines, probation, license suspension, or revocation

What is the standard of proof in a criminal case?

beyond a reasonable doubt

What is a plea bargain?

defendant agrees to a lesser charge instead of proceeding to trial on the original charge

How can unlawful controlled-substance distribution potentially create criminal liability?

if unlawful distribution proximately causes a death, it can potentially result in serious criminal liability

What is the purpose and standard of proof in civil liability?

Purpose: make the injured party whole, usually through money damages

Standard: preponderance of the evidence = more likely than not

What administrative liability can a pharmacist face?

Board of Pharmacy discipline such as fines, probation, suspension, or license revocation

If a pharmacist dispenses the wrong drug and harms a patient, what 3 types of liability could potentially result?

criminal + civil + administrative liability