PharmLaw Set #2 (AZ) Flashcards

Question 1

Q

32-1901.01. Definition of unethical and unprofessional conduct; permittees; licensees
B. In this chapter, unless the context otherwise requires, for the purposes of disciplining a pharmacist or pharmacy intern, “unprofessional conduct” means the following, whether occurring in this state or elsewhere:

Answer

A

Being unfit to practice due to alcohol or drug use.
Dispensing a different drug or brand without explicit permission, except for authorized substitutions.
Claiming professional superiority in compounding or dispensing.
Failing to meet continuing education requirements.
Dispensing a drug without a valid prescription.
Not reporting suspected incompetence or unprofessional conduct of a pharmacist or intern.

Question 2

Q

32-1961.01. Remote dispensing site pharmacies

A remote dispensing site pharmacy shall obtain and maintain a pharmacy license issued by the board.
.
B. A remote dispensing site pharmacy shall meet all of the following requirements:

Answer

A

Ownership: It must be jointly owned by or operate under a contract with a licensed pharmacy in the state.
Supervision: It must be overseen by a pharmacist licensed in the state.
Signage: A visible sign must indicate it is a remote dispensing site under continuous video surveillance with recorded footage.
Recordkeeping: It must use a shared electronic recordkeeping system or allow access to its records by the supervising pharmacy.

Question 3

Q

32-1961.01. Remote dispensing site pharmacies

How many remote dispensing site pharmacies can a pharmacist supervise?

Answer

A

One remote dispensing site pharmacy if the pharmacist is also supervising and dispensing in a licensed pharmacy.
Up to two remote dispensing site pharmacies if the pharmacist is not simultaneously supervising and dispensing at another licensed pharmacy.
Additional remote dispensing site pharmacies with board approval.

Question 4

Q

32-1961.01. Remote dispensing site pharmacies

What are the requirements for a remote dispensing site pharmacy, particularly regarding controlled substances?

Answer

A

Controlled Substances Inventory: The remote dispensing site pharmacy must maintain a perpetual inventory of controlled substances.
Prescription Requirements: All prescriptions for controlled substances (CS) must be electronically prescribed. Paper prescriptions for CS cannot be filled at a remote dispensing site pharmacy.
DEA Regulations: DEA currently treats remote dispensing sites as online pharmacies due to the lack of a specific telepharmacy definition. They must:
- Obtain a modified registration under 21 CFR 1301.19, or
- Meet one of the exceptions to an Online Pharmacy under 21 CFR 1300.04(h).
Operational Requirements: The remote dispensing site pharmacy must:
- Store, hold, and dispense all prescription medications.
- Be jointly owned by a supervising pharmacy or operate under a contract with a licensed pharmacy in the state.
- Be supervised by a licensed pharmacist designated for oversight.
- Display a sign indicating it is a remote dispensing site pharmacy, under continuous video surveillance with recorded footage.
- Use a common electronic recordkeeping system or allow access to all dispensing system records by the supervising pharmacy.

Question 5

Q

32-1966. Acts constituting adulteration of a drug or device
A drug or device shall be deemed to be adulterated:
.
A drug is adulterated if (Select all that apply)

Choose ALL answers that apply.

A
It is partially decomposed

B
It is partially putrid

C
Methods used in its manufacture do not conform with current good manufacturing practices

D
It was packaged in a location that may have exposed it to dust or dirt

E
It is offered for sale under the name of another drug

F
Its container is partially composed of a deleterious substance

G
Its strength differs from that which is recognized in an official compendium

Answer

A

The correct answer is ‘A’ ‘B’ ‘C’ ‘D’ ‘F’ ‘G’

Question 6

Q

What are the key requirements and procedures for pharmacist licensure in Arizona?

Answer

A

License Requirement: To practice as a pharmacist in Arizona, a valid pharmacist license issued by the Board is required. There is no temporary licensure.
Methods of Licensure:
- Practical Examination: Obtain licensure through paper and pencil written testing, computer adaptive testing, or other Board-approved methods.
- Reciprocity: Licensure may also be achieved by reciprocity.
Reinstatement of Delinquent License:
- Practicing Pharmacists: For those with a delinquent license for five or more years and practicing outside Arizona with a valid license, reinstatement requires:
  - Passing the MPJE or Board-approved jurisprudence exam.
  - Paying all delinquent renewal and penalty fees.
- Non-Practicing Pharmacists: For those with a delinquent license for five or more years and not practicing in the last 12 months, reinstatement requires:
  - Meeting the requirements above.
  - Appearing before the Board to provide proof of fitness.
License Verification: A pharmacy permittee or pharmacist-in-charge must verify that a person is currently licensed by the Board before allowing them to practice as a pharmacist.

Question 7

Q

R4-23-202. Licensure by Examination

D. NAPLEX score transfer- What are the procedures for NAPLEX score transfers and licensure by examination in Arizona?

Answer

A

Score Transfer Date: The Board deems a NAPLEX score transfer received on the date NABP transmits the official score transfer report to the Board office.
Application After Passing:
- If an applicant passes the NAPLEX in another jurisdiction, they must apply for licensure in Arizona within 12 months from when the Board receives their official NABP score transfer report.
- After 12 months, they may reapply under subsection (B) or R4-23-203(B).
Application After Failing:
- An applicant who fails the NAPLEX in another jurisdiction may apply for licensure in Arizona under the provisions of subsection (B).

Question 8

Q

R4-23-202. Licensure by Examination

E. Licensure - 1. The Board office shall issue a certificate of licensure and a wall license to a successful applicant upon receipt of:

Answer

A

a. The initial licensure fee specified in R4-23-205, and
b. The wall license fee specified in R4-23-205.

Question 9

Q

R4-23-202. Licensure by Examination

What is required for maintaining a certificate of licensure at a practice site?

Answer

A

A licensee must keep the certificate of licensure at the practice site for inspection by the Board or its designee, and it must be available for review by the public.

Question 10

Q

R4-23-202. Licensure by Examination

G. License renewal - What are the requirements and procedures for renewing a pharmacist license?

Answer

A

Renewal Application: To renew a license, a pharmacist must submit a completed renewal application (either electronically or manually) along with the biennial renewal fee specified in R4-23-205.
Fee and Suspension: If the renewal fee is not paid by November 1 of the renewal year, the pharmacist’s license is suspended, and the licensee cannot practice until the penalty fee is paid as outlined in A.R.S. § 32-1925 and R4-23-205.
Renewal Certificate: The renewal certificate of licensure must be maintained at the practice site for inspection by the Board or its designee, and for public review.
Time Frames: The Board office will adhere to the time frames established in subsection (F) for license renewals.

Question 11

Q

32-1933. Display of license or permit

What are the display and maintenance requirements for permits and licenses?

Answer

A

Permit Display: The holder of a permit must conspicuously display it at the location to which it applies.
License Maintenance: A licensee must maintain their current renewal license (or a duplicate if practicing at multiple locations) at each practice site for inspection by the Board or its designee and for public review.
Duplicate Licenses: If a licensee practices in more than one location, the Board may issue additional duplicate renewal licenses for a fee of up to $25 per duplicate.

Question 12

Q

To renew a pharmacist license in Arizona, Continuing Education requirements include (Select all that apply)

Choose ALL answers that apply.

A
Maintaining records of continuing education hours for at least 2 years

B
Maintaining records of continuing education hours for at least 5 years

C
No carry over of contact hours earned beyond the preceding 2 years

D
Obtaining at least 15 contact hours of continuing education in each of the preceding 2 years

E
Obtaining at least 30 contact hours of continuing education in the preceding 2 years

F
Obtaining at least 3 contact hours of continuing education related to immunizations, vaccines, and emergency medications

G
Obtaining at least 3 contact hours of continuing education related to opioids, substance use disorder, or addiction

Answer

A

The correct answer is ‘B’ ‘C’ ‘E’ ‘G’

Question 13

Q

R4-23-204. Continuing Education Requirements

A. Under A.R.S. § 32-1936, continuing professional pharmacy education is mandatory for all licensees.
.
1. General continuing education requirement. - What are the general continuing education requirements for license renewal??

Answer

A

Requirement: According to A.R.S. § 32-1925(F), the Board will not renew a license unless the licensee has completed 30 contact hours (3.0 CEUs) of continuing education during the two years preceding the renewal application.
Sponsorship: The continuing education must be sponsored by an Approved Provider as defined in R4-23-110.

Question 14

Q

R4-23-204. Continuing Education Requirements

Special continuing education requirement. - What are the special continuing education requirements for license renewal?

Answer

A

For Immunization Certification:
- A licensee certified under R4-23-411 to administer immunizations, vaccines, and emergency medications must complete at least two contact hours of continuing education related to these activities.
For Controlled Substances Dispensing:
- A licensee authorized to dispense controlled substances must complete at least three contact hours of continuing education related to opioids, substance use disorders, or addiction.

Question 15

Q

R4-23-204. Continuing Education Requirements

R4-23-204. Continuing Education Requirements3. A pharmacist is exempt from the continuing education requirement in subsections (A)(1) and (2) between the time of initial licensure and first renewal.
B. Acceptance of continuing education units CEUs. The Board shall:

Answer

A

Accept CEUs for continuing education activities sponsored only by an Approved Provider;
Accept CEUs accrued only during the two-year period immediately before licensure renewal;
Not allow CEUs accrued in a biennial renewal period to be carried forward to the

Question 16

Q

R4-23-204. Continuing Education Requirements

What are the requirements for continuing education records and reporting for pharmacists?

Answer

A

Maintaining Records:
- Verify Participation: Maintain records verifying continuing education activities from the past five years.
- Documentation: Keep a statement of credit or certificate issued by an Approved Provider.
Attesting to CEUs:
- At licensure renewal, attest to the number of CEUs completed during the renewal period on the biennial renewal form.
Submitting Proof:
- Submit proof of continuing education participation to the Board office within 20 days if requested.

Consequences and Appeals:
- Non-compliance: The Board may revoke, suspend, or place the pharmacist’s license on probation for failing to comply with continuing education requirements.
- Appeals: A pharmacist can request a hearing before the Board if they disagree with any Board decision regarding continuing education units.

Question 17

Q

R4-23-204. Continuing Education Requirements

What are the specific rules regarding continuing education units (CEUs) for pharmacists?

Answer

A

No Carry-Forward: CEUs accrued in a biennial renewal period cannot be carried forward to the next renewal period.
CEUs for Presenters: Pharmacists who lead, instruct, or lecture on pharmacy-related topics at a continuing education activity sponsored by an Approved Provider may receive CEUs for their presentation. They must follow the same attendance procedures as other participants.
Normal Teaching Duties: CEUs will not be accepted for the performance of normal teaching duties within a learning institution.

Question 18

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

A pharmacist or a graduate intern or pharmacy intern under the supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication from a prescription order (PART 1):

Answer

A

Oral Prescriptions: Receive, reduce to written form, and manually initial oral prescription orders.
Communication Record: Obtain and record the name of the individual who communicates an oral prescription order.
Patient Information: Obtain and record the patient’s name, address, telephone number, date of birth (or age), gender, individual history, known allergies, and current medications.
Patient Profile: Record comments relevant to the patient’s drug therapy and other specific information.
Legality and Feasibility: Verify the legality and pharmaceutical feasibility of dispensing a drug considering allergies, incompatibilities, drug abuse, signature, and refill frequency.
Dosage Verification: Verify that the dosage is within proper limits.
Prescription Interpretation: Interpret the prescription order and exercise professional judgment.
Preparation: Compound, mix, combine, or prepare and package prescription medications.
Prepackaging Supervision: Supervise or prepackage drugs by pharmacy technicians, verify drugs, labels, and completed procedures, and manually initial labels or logs.
Data Entry Check: Ensure accuracy of prescription order data entry, including patient details, drug information, prescriber’s directions, and practitioner’s information.
Final Accuracy Check: Make a final accuracy check of the completed prescription label, including medication and patient information, and initial the label.

Question 19

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

A pharmacist or a graduate intern or pharmacy intern under the supervision of a pharmacist shall perform the following professional practices in dispensing a prescription medication from a prescription order (PART 2):

Answer

A

Technology-Assisted Verification: If using technology-assisted verification, check final accuracy of prescription labels and initial the finished label; verification of the product is not required.
Prescription Serial Number: Record the prescription serial number and date dispensed on the original prescription order.
Refill Permission: Obtain and record permission to refill a prescription, including the date dispensed, quantity, and medical practitioner’s details.
Communication Records: Reduce new prescription orders received by fax, email, or other means to written or printed form.
Dispensing Verification: Verify that prescription medication is sold to the correct patient, caregiver, or authorized agent.
Dispensing Identification: Record the name or initials of the pharmacist, graduate intern, or pharmacy intern who dispenses the original prescription order.
Refill Identification: Record the name or initials of the pharmacist, graduate intern, or pharmacy intern who dispenses each refill.

Question 20

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

Who is authorized to provide oral consultation about a prescription medication in an outpatient setting, and under what circumstances is it required?

Answer

A

Authorized Individuals: Only a pharmacist, graduate intern, or pharmacy intern may provide oral consultation about a prescription medication to a patient or patient’s caregiver in an outpatient setting, including a patient discharged from a hospital.
Circumstances Requiring Oral Consultation:
1. The medication has not been previously dispensed to the patient in the same strength, dosage form, or with the same directions.
2. The pharmacist, using professional judgment, determines that oral consultation is necessary.
3. The patient or caregiver requests oral consultation.

Question 21

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

C. Oral consultation shall include:

Answer

A

Reviewing the name and strength of a prescription medication or name of a prescription-only device and the labeled indication of use for the prescription medication or prescription-only device;
Reviewing the prescription’s directions for use;
Reviewing the route of administration; and
Providing oral information regarding special instructions and written information regarding side effects, procedure for missed doses, or storage requirements.

Question 22

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

Under what circumstances can oral consultation about a prescription medication be omitted, and what steps must be taken if it is omitted?

Answer

A

Circumstances for Omitting Oral Consultation:
1. The pharmacist, graduate intern, or pharmacy intern determines that oral consultation may be omitted due to professional judgment or circumstances.
Required Steps if Omitting Oral Consultation:
1. Provide written information to the patient or caregiver that summarizes the information typically communicated orally.
2. Document the circumstance and reason for omitting oral consultation using a method approved by the Board or its designee.
3. Offer the patient or caregiver the opportunity to communicate with a pharmacist, graduate intern, or pharmacy intern at a later time and provide a method for contacting them.

Question 23

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

E. The pharmacist or graduate intern or pharmacy intern under the supervision of a pharmacist, through the exercise of professional judgment, may provide oral consultation that includes:

Answer

A

Common severe adverse effects, interactions, or therapeutic contraindications, and the action required if they occur;
Techniques of self-monitoring drug therapy; 3. The duration of the drug therapy; and
Prescription refill information.

Question 24

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

Is a pharmacist, graduate intern, or pharmacy intern required to provide oral consultation if a patient or caregiver refuses it?

Answer

A

No, oral consultation is not required if the patient or patient’s caregiver refuses it.

Question 25

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

How should a pharmacist, graduate intern, or pharmacy intern document the provision or refusal of oral consultation?

Answer

A

When a pharmacist, graduate intern, or pharmacy intern determines to omit oral consultation under subsection (D) and oral consultation is not provided, document, or assume responsibility to document, both the circumstance and reason that oral consultation is not provided; and
Document, or assume responsibility to document, the name, initials, or identification code of the pharmacist, graduate intern, or pharmacy intern who did or did not provide oral consultation.

Question 26

Q

R4-23-402. Pharmacist, Graduate Intern, and Pharmacy Intern

When a prescription is delivered to the patient or patient’s care-giver outside the immediate area of a pharmacy and a pharmacist is not present, the prescription shall be accompanied by written or printed patient medication information that, in addition to the requirements in subsection (C), includes:

Answer

A

Approved use for the prescription medication;
Possible adverse reactions;
Drug-drug, food-drug, or disease-drug interactions;
Missed dose information; and
Telephone number of the dispensing pharmacy or another method approved by the Board or its designee that allows a patient or patient’s care-giver to consult with a pharmacist.

Question 27

Q

R4-23-407. Prescription Requirements
A. Prescription orders. A pharmacist shall ensure that:
1. A prescription order the pharmacist uses to dispense a drug or device includes the following information:

Answer

A

a. Date of issuance;
b. Name and address of the patient for whom or the owner of the animal for which the drug or device is dispensed;
c. Drug name, strength, and dosage form or device name;
d. Name of the manufacturer or distributor of the drug or device if the prescription order is written generically or a substitution is made;
e. Prescribing medical practitioner’s directions for use;
f. Date of dispensing;
g. Quantity prescribed and if different, quantity dispensed;
h. For a prescription order for a controlled substance, the medical practitioner’s address and DEA number;
i. For a written prescription order, the medical practitioner’s signature;
j. For an electronically transmitted prescription order, the medical practitioner’s digital or electronic signature;
k. For an oral prescription order, the medical practitioner’s name and telephone number; and
l. Name or initials of the dispensing pharmacist;

Question 28

Q

R4-23-407. Prescription Requirements
C. Prescription order adaptation. Except for a prescription order for a controlled substance, a pharmacist, using professional judgment, may make the following adaptations to a prescription order if the pharmacist documents the adaptation in the patient’s record:

Answer

A

Change the prescribed quantity if the prescribed quantity is not a package size commercially available from the manufacturer;
Change the prescribed dosage form or directions for use if the change achieves the intent of the prescribing medical practitioner;
Complete missing information on the prescription order if there is sufficient evidence to support the change; and
Extend the quantity of a maintenance drug for the limited quantity necessary to achieve medication refill synchronization for the patient.
.
EXAMPLE: The prescription is issued for 850mg tablets, #30, take 1 tablet otic once daily, 5 refills. You realize the prescriber probably meant PO, by mouth….WE CAN CHANGE IT WITHOUT CALLING :)

Question 29

Q

R4-23-407. Prescription Requirements

E. Transfer of prescription order information. For a transfer of prescription order information to be valid, a pharmacy permittee or pharmacist-in-charge shall ensure that: . . .Record Retention

Answer

A

Both the original and the transferred prescription order must be maintained for seven years after the last dispensing date.

Question 30

Q

R4-23-407. Prescription Requirements

E. Transfer of prescription order information. For a transfer of prescription order information to be valid, a pharmacy permittee or pharmacist-in-charge shall ensure that: . . .Schedule III, IV, or V Controlled Substances

Answer

A

The original prescription order information must be transferred only as specified in 21 CFR 1306.25. (Below)
.
The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database (eg. same chain) may transfer up to the maximum refills permitted by law and the prescriber’s authorization.

Question 31

Q

R4-23-407. Prescription Requirements

E. Transfer of prescription order information. For a transfer of prescription order information to be valid, a pharmacy permittee or pharmacist-in-charge shall ensure that: . . .Noncontrolled Substance Drugs

Answer

A

The original prescription order information can be transferred without limitation up to the number of originally authorized refills.

Question 32

Q

R4-23-407. Prescription Requirements

What conditions must be met for a medical practitioner or their agent to transmit a prescription order for Schedule III, IV, or V controlled substances, prescription-only drugs, or nonprescription drugs to a pharmacy by fax?

Answer

A

Fax Destination:
The prescription order must be faxed only to the pharmacy of the patient’s choice.
.
Prescription Order Information:
The faxed prescription order must contain all the information required for a prescription order in A.R.S. §§ 32-1968 and 36-2525.
The faxed prescription order must be sent only from the medical practitioner’s practice location. However, a nurse in a hospital, long-term care facility, or inpatient hospice may send a fax of a prescription order for a patient of the facility.
.
Additional Fax Information:
The date the prescription order is faxed.
The fax number of the prescribing medical practitioner or the facility from which the prescription order is faxed, and the telephone number of the facility.
The name of the person who transmits the fax, if other than the medical practitioner.

Question 33

Q

R4-23-407. Prescription Requirements

What are the specific rules regarding faxed prescription orders for Schedule II controlled substances?

Answer

A

Information Purposes Only:
A medical practitioner or their agent may fax a prescription order for a Schedule II controlled substance for information purposes only, unless it meets the requirements of A.R.S. § 36-2525(F) and (G).
.
Serving as Original Prescription:
A pharmacy may receive a faxed prescription order for a Schedule II controlled substance for information purposes only. However, if the faxed prescription order meets the requirements of A.R.S. § 36-2525(F) and (G), it may serve as the original written prescription order.

Question 34

Q

R4-23-407. Prescription Requirements

What are the requirements for a pharmacy to retain a faxed prescription order?

Answer

A

To meet the seven-year record retention requirement of A.R.S. § 32-1964, a pharmacy must receive a faxed prescription order on plain paper or make a photocopy of the faxed prescription order

Question 35

Q

R4-23-407. Prescription Requirements

What information must be included in a faxed refill authorization sent by a medical practitioner or their agent?

Answer

A

The faxed authorization must include the medical practitioner’s telephone and fax numbers, the medical practitioner’s signature or the medical practitioner’s agent’s name, and the date of authorization.

Question 36

Q

Prescriptions may be lawfully issued to a pharmacy in Arizona by electronic transmission if

I. For Schedule II Controlled Substances
II. For Schedule III – V Controlled Substances
III. It includes the name of the person transmitting the prescription, if someone other than the practitioner

Choose ALL answers that apply.

Question 37

Q

R4-23-407. Prescription Requirements

G. Electronic transmission of a prescription order from a medical practitioner to a pharmacy.
.
Can a medical practitioner or their agent transmit a prescription order by electronic means, and if so, what are the conditions?

Answer

A

Yes, unless otherwise prohibited by law, a medical practitioner or their agent may transmit a prescription order by electronic means.
.
The transmission can be done directly or through an intermediary, including an E-prescribing network.
.
The electronic transmission must be to the dispensing pharmacy as specified in A.R.S. § 32-1968.
.
The medical practitioner and pharmacy shall ensure all electronic transmissions comply with all the security requirements of state or federal law related to the privacy of protected health information.
.
A medical practitioner or medical practitioner’s agent shall transmit an electronic prescription order only to the pharmacy of the patient’s choice.

Question 38

Q

R4-23-407. Prescription Requirements

G. Electronic transmission of a prescription order from a medical practitioner to a pharmacy.
.
What requirements must be met for the electronic transmission of a Schedule II, III, IV, or V controlled substance prescription order?

Answer

A

For electronic transmission of a Schedule II, III, IV, or V controlled substance prescription order, the medical practitioner and pharmacy shall ensure the transmission complies with any security or other requirements of federal law.

Question 39

Q

R4-23-407. Prescription Requirements

G. Electronic transmission of a prescription order from a medical practitioner to a pharmacy.
.
4. In addition to the information required to be included on a prescription order as specified in A.R.S. § 32-1968, a medical practitioner shall ensure an electronically transmitted prescription order includes:

Answer

A

a. The date of transmission; and
b. If the individual transmitting the prescription is not the medical practitioner, the name of the medical practitioner’s authorized agent who transmits the prescription order.

Question 40

Q

36-2525. Prescription orders; labels; packaging; definition

What are the requirements and exceptions for dispensing Schedule II controlled substances?

Answer

A

Schedule II controlled substances must be dispensed with either: A written prescription order in ink, indelible pencil, or typewritten and manually signed by the medical practitioner, or
An electronic prescription order as prescribed by federal law or regulation.
Starting January 1, 2020, a Schedule II controlled substance that is an opioid can only be dispensed with an electronic prescription order.
Prescription orders for Schedule II controlled substances cannot be dispensed more than 90 days after the date they were issued.
A Schedule II controlled substance prescription cannot be refilled.
A pharmacy may sell and dispense a Schedule II controlled substance prescribed by a medical practitioner in another state if the prescription complies with the laws of the prescribing practitioner’s state and federal law.
In emergency situations or other specific conditions outlined in subsections E, F, and G, exceptions to these rules apply.

Question 41

Q

R4-23-408. Computer Records
A. Systems manual. A pharmacy permittee or pharmacist-in-charge shall:
1. Develop, implement, and comply with policies and procedures for the following operational aspects of a computer system:

Answer

A

a. Examples of all output documentation provided by the computer system that contains original or refill prescription order or patient profile information;
b. Steps a pharmacy employee follows when the computer system is not operational due to scheduled or unscheduled system interruption;
c. Regular and routine backup file procedure and file maintenance, including secure storage of backup files;
d. Audit procedures, personnel code assignments, and personnel responsibilities; and
e. Quality assurance mechanism for data entry validation;

Question 42

Q

R4-23-408. Computer Records
A. Systems manual. A pharmacy permittee or pharmacist-in-charge shall: (additional)

Answer

A

Review the policies and procedures biennially and revise them if necessary.
Document the biennial review of the policies and procedures.
Assemble the policies and procedures into a written manual or by another method approved by the Board or its designee.
Make the policies and procedures available within the pharmacy for reference by pharmacy personnel.
Ensure the policies and procedures are accessible for inspection by the Board or its designee.

Question 43

Q

R4-23-408. Computer Records

B. Computer system data storage and retrieval. A pharmacy permittee or pharmacist-in-charge shall ensure the computer system is capable of:… What capabilities must a pharmacy’s computer system have for data storage and retrieval?

Answer

A

A pharmacy permittee or pharmacist-in-charge must ensure the computer system can:
1. Produce sight-readable information on all original and refill prescription orders and patient profiles.
2. Provide online retrieval (via CRT display or hard-copy printout) of original prescription order information as required in A.R.S. § 32-1968(C), R4-23-402(A), and R4-23-407(A).
3. Provide online retrieval (via CRT display or hard-copy printout) of patient profile information as required in R4-23-402(A).
4. Identify the pharmacist responsible for dispensing each original or refill prescription order. (Pharmacies using systems before the effective date of this section that cannot provide this documentation must use manual documentation.)
5. Produce a printout of all prescription order information, including a single-drug usage report with:
- The name of the prescribing medical practitioner.
- The name and address of the patient.
- The quantity dispensed on each original or refill prescription order.
- The date of dispensing for each original or refill prescription order.
- The name or identification code of the dispensing pharmacist.
- The serial number of each prescription order.
6. Provide a printout of requested prescription order information to an individual pharmacy within 72 hours if the information is maintained in a centralized computer record system.

Question 44

Q

R4-23-408. Computer Records
C. A pharmacy permittee or pharmacist-in-charge of a pharmacy that uses a pharmacy computer system: What requirements must a pharmacy permittee or pharmacist-in-charge follow for a pharmacy that uses a pharmacy computer system?

Answer

A

A: The pharmacy permittee or pharmacist-in-charge must:
1. Notify the DEA and the Board in writing that original and refill prescription order information and patient profiles are stored in a pharmacy computer system.
2. Comply with the specified section if the pharmacy computer system’s refill records are used as an alternative to the manual refill records required in R4-23-407(B).
3. Be exempt from the manual refill recordkeeping requirements of R4-23-407(B) if the pharmacy computer system complies with the specified section.
4. Ensure that documentation of the accuracy of original and refill prescription order information entered into a computer system is provided by each pharmacist using the computer system and kept on file in the pharmacy for seven years from the date of the last refill. Documentation includes:
- Option A: A hard-copy printout of each day’s original and refill prescription order data that:
- States that original and refill data for prescriptions dispensed by each pharmacist is reviewed for accuracy.
- Includes the printed name of each dispensing pharmacist.
- Is signed and initialed by each dispensing pharmacist.
- Option B: A log book or separate file of daily statements that:
- States that original and refill data for prescriptions dispensed by each pharmacist is reviewed for accuracy.
- Includes the printed name of each dispensing pharmacist.
- Is signed and initialed by each dispensing pharmacist.

Question 45

Q

R4-23-408. Computer Records
D. What actions must a pharmacy permittee or pharmacist-in-charge take if the pharmacy computer system does not comply with the requirements of subsections (A), (B), and (F)?

Answer

A

A: If the pharmacy computer system does not comply with the requirements of subsections (A), (B), and (F), the pharmacy permittee or pharmacist-in-charge must:
1. Bring the computer system into compliance within three months of receiving a notice of noncompliance or a violation letter.
2. If the computer system is still noncompliant after three months, immediately comply with the manual recordkeeping requirements of R4-23-402 and R4-23-407.

Question 46

Q

R4-23-408. Computer Records
E. What steps must a pharmacy’s personnel follow if they are performing manual recordkeeping due to a noncompliant computer system?

Answer

A

If a pharmacy’s personnel are performing manual recordkeeping due to a noncompliant computer system, they must:
1. Continue manual recordkeeping until the pharmacist-in-charge sends proof that the computer system is compliant with subsections (A), (B), and (F).
2. Ensure that the proof of compliance is verified by a Board compliance officer.

Question 47

Q

R4-23-408. Computer Records
F. Security. To maintain the confidentiality of patient records, a pharmacy permittee or pharmacist-in-charge shall ensure:

Answer

A

The computer system has security and systems safeguards designed to prevent and detect unauthorized access, modification, or manipulation of prescription order information and patient profiles; and
After a prescription order is dispensed, any alteration of prescription order information is documented, including the identification of the pharmacist responsible for the alteration.

Question 48

Q

R4-23-408. Computer Records
G. A computer system that does not comply with all the requirements of subsections (A), (B), and (F) may be used in a pharmacy if:

Answer

A

The computer system was in use in the pharmacy before July 11, 2001, and
The pharmacy complies with the manual recordkeeping requirements of R4-23-402 and R4-23-407.

Question 49

Q

R4-23-410. Current Good Compounding Practices
C. A pharmacy permittee shall ensure compliance with the organization, training, and personnel issues in this subsection.
1. Before dispensing a compounded pharmaceutical product, a pharmacist:

Answer

A

a. Inspects and approves or rejects, or assumes responsibility for inspecting and approving or rejecting, components, pharmaceutical product containers and closures, in-process materials, and labeling;
b. Prepares or assumes responsibility for preparing all compounding records;
c. Reviews all compounding records to ensure that no errors occur in the compounding process;
d. Ensures the proper use, cleanliness, and maintenance of all compounding equipment; and
e. Documents by hand-written initials or signature in the compounding record the completion of the requirements of subsections (C)(1)(a), (b), (c), and (d).

Question 50

Q

R4-23-410. Current Good Compounding Practices
C. A pharmacy permittee shall ensure compliance with the organization, training, and personnel issues in this subsection.
2. A pharmacist engaged in compounding:

Answer

A

a. Complies with the current good compounding practices and applicable state pharmacy laws;
b. Maintains compounding proficiency through current awareness, training, and continuing education; and
c. Ensures that personnel engaged in compounding wear:
i. Clean clothing appropriate to the work performed; and
ii. Protective apparel, such as coats, aprons, gowns, gloves or masks to protect the personnel from chemical exposure and prevent pharmaceutical product contamination.

Question 51

Q

R4-23-410. Current Good Compounding Practices
D. A pharmacy permittee shall ensure the security, safety, and quality of a compounded pharmaceutical product by conforming with the following standards:

Answer

A

Procedures must be implemented to:
1. Exclude anyone with an illness or open lesion from direct contact with pharmaceutical components and products until cleared by medical personnel.
2. Require personnel to inform a pharmacist of any health condition that may affect the quality or safety of a compounded pharmaceutical product.

Question 52

Q

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition
.
What must a pharmacist do to order and administer immunizations and vaccines?

Answer

A

A pharmacist must update their online profile with the board to indicate they are an active immunizer and meet the board’s requirements as prescribed by rule.

Question 53

Q

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition
.
D. A pharmacist who is authorized to order and administer immunizations and vaccines pursuant to this section may order and administer:

Answer

A

Emergency medication to manage an acute allergic reaction to an immunization, vaccine or medication in accordance with guidelines from the United States centers for disease control and prevention’s advisory committee on immunization practices for adults and the American academy of pediatrics for minors.
Immunizations or vaccines to any person regardless of age during a public health emergency response of this state pursuant to section 36-787.

Question 54

Q

32-1974. Pharmacists; administration of immunizations, vaccines and emergency medications; authorization; reporting requirements; advisory committee; definition
.
E. A pharmacist who administers an immunization, vaccine or emergency medication pursuant to this section must:

Answer

A

A: A pharmacist must:
1. Notify the person’s primary care provider or physician within forty-eight hours after administration, making a reasonable effort to identify the provider by checking the Arizona state immunization information system, pharmacy records, or requesting information from the person or their guardian.
2. Report information to the Arizona state immunization information system.
3. Maintain a record of the immunization as required by law and board rules.
4. Notify the person’s primary care provider or physician within twenty-four hours of any adverse reaction that is reported or witnessed and listed by the vaccine manufacturer as a contraindication to further doses of the vaccine.

Question 55

Q

R4-23-412. Emergency Refill Prescription Dispensing

What are the conditions under which a pharmacist may dispense a one-time emergency refill prescription during a state of emergency?

Answer

A

During a state of emergency declared under A.R.S. § 32-1910(A) or (B), a pharmacist may dispense a one-time emergency refill prescription of up to a 30-day supply if:
1. The medication is essential to the maintenance of life or to the continuation of therapy, as determined by the pharmacist’s professional opinion.
2. The pharmacist makes a good faith effort to reduce the information to a written prescription marked “emergency prescription” and files and maintains the prescription as required by law.

Question 56

Q

R4-23-502. Requirements for Data Format and Transmission

What information must a dispenser submit to the Board regarding each prescription dispensed for a controlled substance in Schedules II, III, and IV?

Answer

A

A dispenser must submit the following information by electronic means for each prescription dispensed for a controlled substance listed in Schedules II, III, and IV:
1. Dispenser’s name, address, telephone number, prescription number, and DEA registration number.
2. Name, address, gender, date of birth, and telephone number of the person (or owner if for an animal) for whom the prescription is written.
3. Prescribing medical practitioner’s name, address, telephone number, and DEA registration number.
4. Quantity and National Drug Code (NDC) number of the controlled substance dispensed.
5. Date the prescription was dispensed.
6. Number of refills authorized by the medical practitioner.
7. Date the prescription was issued.
8. Method of payment (cash or third party).
9. Whether the prescription is new or a refill.

Question 57

Q

R4-23-502. Requirements for Data Format and Transmission

What is the reporting schedule for dispensers to submit required information on controlled substances?

Answer

A

Dispensers must report the required information by the close of business each Friday for the previous week (Sunday through Saturday).
- If Friday is a state holiday, the information must be reported on the following business day.
- The Board or its designee may approve a less frequent reporting period if the dispenser demonstrates that it will not reduce the system’s effectiveness or jeopardize public health.

Question 58

Q

R4-23-607. Nonresident Permits

What are the requirements for a nonresident to sell or distribute controlled substances or drugs in Arizona?

Answer

A

A nonresident must have:
1. A current Board-issued permit, such as a nonresident pharmacy permit, nonresident manufacturer permit, nonresident full-service or nonprescription drug wholesale permit, or nonresident nonprescription drug permit.
2. A current equivalent license or permit issued by the licensing authority in the jurisdiction where the person resides.

Question 59

Q

E. Drug sales.

What are the restrictions for a nonresident pharmacy permittee regarding drug sales into Arizona?

Answer

A

A nonresident pharmacy permittee must:
1. Controlled Substances and Prescription-Only Drugs:
- Not sell, distribute, give away, or dispose of to anyone in Arizona except:
- A pharmacy, drug manufacturer, or full-service drug wholesaler permitted by the Board.
- A medical practitioner licensed under A.R.S. Title 32.
- An Arizona resident with a valid prescription order.

Nonprescription Drugs, Precursor Chemicals, and Regulated Chemicals:
- Not sell, distribute, give away, or dispose of to anyone in Arizona except:
  - A pharmacy, drug manufacturer, full-service or nonprescription drug wholesaler, or nonprescription drug retailer permitted by the Board.
  - A medical practitioner licensed under A.R.S. Title 32.
  - An Arizona resident either with a valid prescription order or in the original manufacturer’s container.

Question 60

Q

A pharmacy in California that has a valid prescription for a resident of Arizona, may ship prescription-only drugs,

A
but not controlled substances, into Arizona as long as they hold a current pharmacy licensed in California

B
but not controlled substances, into Arizona as long as they hold a current pharmacy licensed in California as well as a non-resident pharmacy permit in Arizona

C
including controlled substances, into Arizona as long as they hold a current pharmacy licensed in California

D
including controlled substances, into Arizona as long as they hold a current pharmacy licensed in California as well as a non-resident pharmacy permit in Arizona

Question 61

Q

A community pharmacy in Arizona

I. Must have the pharmacist-in-charge review all pharmacy policies and procedures at least once every 2 years, and make the policies and procedures available in the pharmacy for employee reference
II. May be unlocked and opened each day by a pharmacist or pharmacy intern
III. Must keep the pharmacy area locked when a pharmacist is not present

Answer

A

I and III

Question 62

Q

R4-23-610. Community Pharmacy Personnel and Security Procedures

What are the responsibilities of the pharmacist-in-charge at a community pharmacy?

Answer

A

The pharmacist-in-charge must:
1. Ensure Communication and Compliance:
- Ensure Board directives are communicated and complied with by management, other pharmacists, interns, and technicians.

Pharmacy Policies and Procedures:
- Prepare, Implement, and Comply: Ensure all pharmacy policies and procedures required under 4 A.A.C. 23 are prepared, implemented, and followed.
- Biennial (every 2 year) Review: Review and, if necessary, revise all pharmacy policies and procedures biennially.
- Document Review: Document the biennial review of policies and procedures.
- Assemble Manual: Assemble all pharmacy policies and procedures as a written or electronic manual.
- Availability: Make all policies and procedures available in the pharmacy for employee reference and inspection by the Board or its staff.

Question 63

Q

R4-23-610. Community Pharmacy Personnel and Security Procedures

What are the personnel permitted in the pharmacy area of a community pharmacy, and what are the conditions for their presence?

Answer

A

Permitted Personnel:
- Pharmacists
- Graduate interns
- Pharmacy interns
- Compliance officers
- Drug inspectors
- Peace officers acting in their official capacity
- Persons authorized by law
- Pharmacy technicians
- Pharmacy technician trainees
- Support personnel
- Other designated personnel
Conditions for Presence:
- Pharmacy interns, graduate interns, pharmacy technicians, pharmacy technician trainees, support personnel, and other designated personnel are permitted in the pharmacy area only when a pharmacist is on duty, except in an extreme emergency as defined in R4-23-110.
- The pharmacist-in-charge must comply with the minimum area requirements as described in R4-23-609 for a community pharmacy and for compounding and dispensing counter areas.
- A pharmacist employed by the pharmacy must ensure that the pharmacy is physically secure while the pharmacist is on duty.

Question 64

Q

R4-23-610. Community Pharmacy Personnel and Security Procedures

What are the security requirements for the pharmacy area and additional storage areas in a community pharmacy?

Answer

A

Pharmacy Area Security:
- The pharmacist must ensure that the pharmacy area and any additional storage area for drugs restricted to access only by a pharmacist are locked when a pharmacist is not present, except in an extreme emergency.
Access Control:
- Only a pharmacist is permitted to unlock the pharmacy area or any additional storage area for drugs restricted to access only by a pharmacist, except in an extreme emergency.

Answer 63

A

Transfer to Pharmacy Area:
- Prescription-only drugs and controlled substances received outside the pharmacy area must be immediately transferred, unopened, to the pharmacy area.
Opening and Marking:
- Shipments of prescription-only drugs and controlled substances must be opened and marked by pharmacy personnel in the pharmacy area, under the supervision of a pharmacist, graduate intern, or pharmacy intern.

Answer 64

A

Yes, a pharmacy permittee or pharmacist-in-charge may provide a small opening or slot through which a written prescription order or a prescription medication container to be refilled may be left in the prescription area when the pharmacist is not present.

Answer 65

A

The pharmacist must ensure that prescription medication is either:
1. Delivered directly to the patient, or
2. Secured inside the locked pharmacy.

However, if an automated storage and distribution system that complies with R4-23-614 is used, these requirements may be different.

Answer 66

A

The notice must include:

The name, address, pharmacy permit number, and D.E.A. registration number of the pharmacy discontinuing business.
The name, address, pharmacy permit number (if applicable), and D.E.A. registration number (if applicable) of the licensee, permittee, or registrant to whom any narcotic or other controlled substance, prescription-only drug or device, nonprescription drug, precursor chemical, or regulated chemical will be sold or transferred.
The name and address of the location where the discontinuing pharmacy’s records of purchase and disbursement will be kept, and the person responsible for these records, which must be retained for a minimum of three years from the discontinuation date.
The name and address of the location where the pharmacy’s prescription files and patient profiles will be kept, and the person responsible for these files and profiles, which must be retained for a minimum of seven years from the date the last prescription was dispensed.
The proposed date of discontinuing business operations.

Answer 67

A

The following actions must be completed:

Remove Signs and Symbols: Ensure that all pharmacy signs and symbols are removed from both the inside and outside of the premises.
Return Permits and Certificates: Return all state permits and certificates of registration to the Board office.
Return D.E.A. Documents: Return D.E.A. registration certificates and unused D.E.A. Schedule II order forms to the D.E.A. Regional Office in Phoenix.

Answer 68

A

The licensee, permittee, or registrant must:

Contact a Reverse Distributor: Reach out to a D.E.A.-registered reverse distributor for the proper destruction of outdated or damaged controlled substances.
Board Inspection Request: If the reverse distributor will not accept certain controlled substances, contact the Board office to request an inspection for the purpose of drug destruction.

Answer 69

A

During the three-year record retention period specified in subsection (A)(3), the person responsible for the discontinued pharmacy’s records must:

Provide Records to the Board: Furnish the Board with records of the purchase and disbursement of narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals upon request.

Answer 70

A

The pharmacist-in-charge must ensure the following:

Access to Drugs: Only a pharmacist has access to prescription-only drugs and controlled substances until they are transferred.
Removal of Drugs: All narcotics, controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals must be removed from the premises on or before the discontinuation date.
Transfer of Controlled Substances:
- Inventory: Take an inventory of all controlled substances being transferred using the procedures in R4-23-1003.
- Documentation: Include a copy of the inventory with the transferred controlled substances.
- Record Keeping: Keep the original inventory with the discontinued pharmacy’s records for a minimum of three years.
- D.E.A. Form 222: Use D.E.A. Form 222 to transfer any Schedule II controlled substances.
- Destruction: Transfer controlled substances requiring destruction in the same manner as other controlled substances.

Answer 71

A

During the seven-year record retention period specified in subsection (A)(4), the person responsible for the discontinued pharmacy’s records must:

Provide Records to the Board: Furnish the Board with records of prescription files and patient profiles upon request.

Answer 72

A

A pharmacy permittee or pharmacist-in-charge must ensure that a mechanical storage and counting device complies with the following:

Identification of Contents:
- The drug name and strength are affixed to the front of each cell or cassette.
Paper or Electronic Log Requirements:
- Identification: Log each cell or cassette by drug name and strength or cell/cassette number.
- Manufacturer Info: Include the drug’s manufacturer or National Drug Code (NDC) number.
- Expiration and Lot Info: Document the expiration date and lot number from the manufacturer’s stock bottle. If multiple lot numbers are used, each lot number and expiration date must be documented, with the earliest expiration date being used for the mixed lot.
- Filling Date: Record the date the cell or cassette is filled.
- Filling Identity: Document the identity of the licensee who filled the cell or cassette.
- Supervision: If the filling licensee is not a pharmacist, record the identity of the pharmacist who supervised the filling.
Log Availability:
- The log must be available in the pharmacy for inspection by the Board or its designee for not less than two years.

Answer 73

A

A pharmacy permittee or pharmacist-in-charge must ensure the following:

Drug Return Restrictions:
- Any drug previously counted by a mechanical storage and counting device that has not left the pharmacy cannot be returned to the drug’s cell, cassette, or stock bottle unless the return method is approved by the Board or its designee as specified in subsection (G).
Exceptions:
- This restriction does not prevent the use of a manual or mechanical counting device to count and dispense a previously counted drug, provided that the drug is dispensed before its beyond-use date.

Answer 74

A

The pharmacy permittee or pharmacist-in-charge must ensure the following:

Training:
- Document training in the maintenance, calibration, and use of the mechanical storage and counting device for each employee who uses the device.
Maintenance and Calibration:
- Perform maintenance and calibration of the device as recommended by the manufacturer.
Quality Assurance:
- Conduct routine quality assurance and accuracy validation testing for each mechanical storage and counting device.

Answer 75

A

The pharmacy permittee or pharmacist-in-charge must:

Prepare and Implement Policies:
- Ensure that policies and procedures for the performance and use of the mechanical storage and counting device are prepared, implemented, and complied with.
Biennial Review:
- Review the policies and procedures biennially and revise them if necessary.
Document Review:
- Document the biennial review of the policies and procedures.
Assemble Manual:
- Assemble the policies and procedures into a written or electronic manual.
Availability:
- Make the policies and procedures available within the pharmacy for employee reference and inspection by the Board or its staff.

Answer 76

A

Implementation or Participation:
- Each pharmacy permittee must implement or participate in a CQA program. This requirement is met if the pharmacy holds a current general, special, or rural general hospital license from the Arizona Department of Health Services and is:
  - Certified by the Centers for Medicare and Medicaid Services,
  - Accredited by the Joint Commission on the Accreditation of Healthcare Organizations, or
  - Accredited by the American Osteopathic Association.
Development and Utilization:
- The pharmacy must develop, implement, and utilize a CQA program consistent with A.R.S. § 32-1973. Medication error data must be reviewed regularly. Training records, policies, procedures, and other program documents must be maintained for a minimum of two years.
Policies and Procedures:
- Policies and procedures for the CQA program must be:
  - Prepared, implemented, and complied with,
  - Reviewed biennially and revised as needed,
  - Documented,
  - Assembled into a written or electronic manual,
  - Available within the pharmacy for employee reference and Board inspection.
Planned Processes:
- The CQA program policies and procedures must address:
  - Training for all pharmacy personnel,
  - Identification and documentation of medication errors,
  - Recording, measuring, and analyzing data to assess causes and improve patient care,
  - Developing systems and workflows to prevent or reduce medication errors,
  - Periodic communication with pharmacy personnel to review findings and updates.
Regulatory Oversight:
- The Board’s oversight is limited to inspecting the pharmacy’s CQA policies and procedures and enforcing compliance.
Mitigating Factor:
- Compliance with the CQA program may be considered a mitigating factor in the investigation and evaluation of medication errors.

Answer 77

A

Medication Order Verification:
- Verify a patient’s medication order before administration, except in emergencies or, in hospitals with less than 24-hour pharmacy services, within four hours of the pharmacy opening.
Medication Order Feasibility:
- Verify the medication order’s pharmaceutical and therapeutic feasibility considering:
  - The patient’s medical condition,
  - Allergies,
  - Pharmaceutical and therapeutic incompatibilities,
  - Recommended dosage limits.
Drug Preparation:
- Measure, count, pour, or prepare drugs for dispensing. Pharmacy technicians or trainees may perform these tasks under pharmacist supervision according to Board-approved policies.
Drug Compounding:
- Compound, admix, combine, or prepare drugs for dispensing. Pharmacy technicians may do so under pharmacist supervision according to approved policies.
Verification of Technician Work:
- Verify the accuracy and safety of drugs prepared by pharmacy technicians or trainees, including procedures and compliance with policies.
Drug Repackaging:
- Supervise drug repackaging and check the completed product as specified.
Training and Education:
- Supervise training in aseptic technique and drug incompatibilities for personnel involved in parenteral product admixture.
Consultation:
- Consult with medical practitioners about patient drug therapy or medical conditions.
Patient Consultation:
- Provide consultation regarding medication orders, patient profiles, or drug therapy when requested or deemed necessary.
Drug Therapy Monitoring:
- Monitor patient drug therapy for safety and effectiveness.
Drug Information:
- Provide drug information to patients and healthcare professionals.
Personnel Management:
- Manage pharmacy technicians and other personnel to ensure accuracy, safety, and risk-free operations.
Medication Order Accuracy:
- Verify the accuracy of all aspects of the medication order.
Quality Assurance Compliance:
- Ensure pharmacy personnel comply with the hospital’s quality assurance program.

Answer 78

A

A hospital pharmacy permittee must ensure that the hospital pharmacy has sufficient equipment and physical facilities to properly compound, dispense, and store drugs, including parenteral preparations.

Answer 79

A

The minimum area of a hospital pharmacy depends on the type of hospital, the number of beds, and the pharmaceutical services provided. For any hospital pharmacy permit issued or hospital pharmacy remodeled after January 31, 2003, the minimum area primarily devoted to drug dispensing and preparation functions, exclusive of bulk drug storage, satellite pharmacy, and office areas, must be at least 500 square feet. The minimum area requirement may be varied upon approval by the Board for out-of-the-ordinary conditions or for systems that require less space.

Answer 80

A

The Board may require a hospital pharmacy permittee or applicant to provide more than the minimum area if any of the following conditions are met:
1. Crowding interferes with safe pharmacy practice due to equipment, inventory, personnel, or other factors.
2. There is a need for additional dispensing, preparation, or storage areas because of:
- An increased number of specific drugs prescribed per day.
- Increased use of intravenous and irrigating solutions.
- Increased use of disposable and prepackaged products.
3. There is a need to handle special items such as:
- Investigational drugs.
- Emergency drug kits.
- Chemotherapeutic agents.
- Alcohol and other flammables.
- Poisons.
- External preparations.
- Radioisotopes.
- Quality control procedures.
4. Additional office space is needed to accommodate:
- An increased number of personnel.
- A drug information library.
- A poison information library.
- Research support.
- Teaching and conference areas.
- A waiting area.

Answer 81

A

A hospital pharmacy permittee shall ensure that the hospital pharmacy area is:
- Enclosed by a permanent barrier or partition from floor to ceiling.
- Equipped with entry doors that can be securely locked.
- Constructed according to the specifications outlined in R4-23-609(F).

Answer 82

A

The hospital pharmacy permittee, Director of Pharmacy, or pharmacist-in-charge shall ensure that all undispensed or undistributed drugs are stored in designated areas within the hospital pharmacy or other locked areas under the control of a pharmacist. These storage areas must ensure:
- Proper sanitation
- Appropriate temperature control
- Adequate light
- Sufficient ventilation
- Moisture control
- Proper segregation
- Security

Answer 83

A

For use inside the hospital.
a. Labels for all single unit packages contain at a minimum, the following information:
i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date; and
iii. Appropriate auxiliary labels;
b. Labels for repackaged preparations contain at a minimum the following information:
i. Drug name, strength, and dosage form;
ii. Lot number and beyond-use-date;
iii. Appropriate auxiliary labels; and
iv. Mechanism to identify pharmacist accountable for repackaging;
c. Labels for all intravenous admixture preparations contain at a minimum the following information:
i. Patient’s name and location;
ii. Name and quantity of the basic parenteral solution;
iii. Name and amount of drug added;
iv. Date of preparation;
v. Beyond-use-date and time;
vi. Guidelines for administration;
vii. Appropriate auxiliary label or precautionary statement; and
viii. Initials of pharmacist responsible for admixture preparation; and
For use outside the hospital. Any drug dispensed to a patient by a hospital pharmacy that is intended for self-administration outside of the hospital is labeled as specified in A.R.S. §§ 32-1963.01(C) and 32-1968(D) and A.A.C. R4-23-402.

Answer 84

A

Specifically ordered by a medical practitioner, and
The patient is educated and trained in the proper manner of self-administration.

Answer 85

A

The Director of Pharmacy or pharmacist-in-charge, in consultation with the appropriate department personnel and medical staff committee, must develop, implement, review, and revise policies and procedures for patient-owned drugs brought into the hospital. The policies and procedures must specify the following criteria:

Administration of Patient-Owned Drug:
- A pharmacist or medical practitioner must identify the drug.
- A medical practitioner must write a medication order specifying the administration of the identified patient-owned drug.
Non-Usage During Hospitalization:
- If the patient-owned drug will not be used during the patient’s hospitalization, the hospital pharmacy personnel must:
  - Package, seal, and give the drug to the patient’s agent for removal from the hospital, or
  - Package, seal, and store the drug for return to the patient at the time of discharge from the hospital.

Answer 86

A

The Director of Pharmacy or pharmacist-in-charge is responsible for:

The receipt, storage, distribution, and accountability of drug samples within the hospital.
Developing, implementing, reviewing, and revising policies and procedures regarding drug samples in the same manner described in R4-23-653(A).
Ensuring compliance with the specific policies and procedures regarding drug samples.

Answer 87

A

Compounding Sterile Pharmaceutical Products: Key Requirements

Environment Standards:
- Compounding parenteral or injectable sterile products from non-sterile ingredients must occur in an ISO class 5 environment within an ISO class 7 environment.
- The ISO class 7 environment must not include a prep area inside it.
Protective Clothing:
- Personnel must wear protective clothing, including a gown, gloves, head cover, and booties.
- Protective clothing is not required if all compounding occurs within an ISO class 5 environment isolator that is not inside an ISO class 7 environment.
Aseptic Technique Validation:
- Personnel must complete a semi-annual media-fill test using dry non-sterile media to validate proper aseptic technique under the most challenging conditions.

Answer 88

A

Only a person with a Board-issued permit to operate a pharmacy in Arizona can apply for this permit. A separate permit is required for each kiosk, and the application must be submitted with the specified fee. The permit holder must designate a pharmacist in charge of the kiosk. Additionally, kiosks cannot be placed in gas stations or convenience stores.

Answer 89

A

If a pharmacist will not be on duty, the Director of Pharmacy or pharmacist-in-charge must arrange for medical staff and other authorized personnel to access drugs in the remote drug storage area or the hospital pharmacy if necessary. Additionally, a pharmacist must be on-call during all absences.

Answer 90

A

They must arrange for the medical staff and other authorized personnel to have telephone access to an on-call pharmacist.

Answer 91

A

The hospital pharmacy permittee must ensure that the hospital pharmacy is not without a pharmacist on duty for more than 72 consecutive hours.

Answer 92

A

Develop and maintain an inventory listing of the drugs to be included in a remote drug storage area; and
Develop, implement, review, and revise in the same manner described in R4-23- 653(A) and comply with policies and procedures that ensure proper storage, access, and accountability for drugs in a remote drug storage area.

Answer 93

A

If a drug is not available from a remote drug storage area and is required to treat a patient’s immediate needs, the hospital pharmacy can be accessed according to these requirements:

The Director of Pharmacy or pharmacist-in-charge must:
- Develop, implement, review, and revise policies and procedures for pharmacy access during the pharmacist’s absence.
- Ensure access is delegated to only one supervisory nurse per shift.
- Communicate the policy and the supervisory nurse’s name in writing to the hospital’s medical staff.
- Ensure the designated nurse has been trained in proper access, drug removal, and recordkeeping procedures.
- Allow delegation of access by the supervisory nurse to another nurse only in an emergency.
The nurse accessing the pharmacy must:
- Record the patient’s name, drug name, strength, dosage form, quantity removed, and the date and time of removal on a form.
- Sign or initial the form recording the drug removal.
- Attach the original or a copy of the medication order to the form.
- Place the form conspicuously in the hospital pharmacy.
Within four hours after the pharmacist returns, they must verify all records of drug removal that occurred during their absence.

Answer 94

A

A prescription medication is provided to a long-term care facility resident only with a valid prescription order, properly labeled for that resident. Nonprescription drugs can be supplied in the manufacturer’s unopened container or through an emergency drug supply unit as specified in R4-23-701.02.
A prescription medication label for a resident must comply with A.R.S. §§ 32-1968 and 36-2525, including the drug name, strength, dosage form, quantity, and beyond-use-date.
Only a pharmacist from the dispensing pharmacy can relabel or alter an illegible or missing prescription medication label.
The provider pharmacy must have drug recall policies and procedures to protect the health and safety of residents, including the immediate discontinuation of recalled drugs and notifying the prescriber and director of nursing.
Drugs previously dispensed to a resident by another pharmacy or previously dispensed by the provider pharmacy are not to be repackaged.

Answer 95

A

Emergency Drug Supply Unit Policies and Procedures for Long-Term Care Facilities

Develop and Maintain Policies: Prepare, implement, review, and revise written policies and procedures for the storage and use of an emergency drug supply unit in a long-term care facility as outlined in R4-23-671(E).
Accessibility: Ensure policies and procedures are available in the provider pharmacy and long-term care facility for employee reference and inspection by the Board or its staff.
Content of Policies and Procedures: Include the following in the written policies and procedures:
- Drug Removal Procedures:
  - Long-term care facility personnel must receive a valid prescription order for each drug removed from the emergency drug supply unit.
  - Long-term care facility personnel must notify the provider pharmacy when a drug is removed.
- Outdated Drug Replacement Procedures
- Security and Inspection Procedures
Restocking Procedures: Exchange or restock the emergency drug supply unit weekly, or more frequently if necessary, to maintain an adequate supply of emergency drugs. Restocking must be done by an Arizona licensed pharmacist employed by the provider pharmacy or by an Arizona licensed intern, graduate intern, technician, or technician trainee under the direct onsite supervision of an Arizona licensed pharmacist.
Education: Educate pharmacy and long-term care facility personnel on the storage and use of the emergency drug supply unit.

Answer 96

A

A: The pharmacy permittee or pharmacist-in-charge must ensure the following:

1. Drug Stocking Procedures:
- Non-removable Containers:
- Must be stocked at the long-term care facility by an Arizona licensed pharmacist employed by the provider pharmacy, or by an Arizona licensed intern, graduate intern, technician, or technician trainee under the direct onsite supervision of an Arizona licensed pharmacist.
- Utilize bar code or other technologies to ensure the correct drug is placed in the correct canister or container.
- Removable Containers:
- Prepackaging of the container occurs at the provider pharmacy.
- A pharmacist verifies the container has been properly filled and labeled, and the container is secured with a tamper-evident seal.
- Individual containers are transported to the long-term care facility in a secure, tamper-evident shipping container.
- The automated dispensing system uses microchip, bar-coding, or other technologies to ensure the containers are accurately loaded in the automated dispensing system.

2. Recordkeeping and Report Procedures:
- All events involving access to the automated dispensing system are recorded electronically and maintained for not less than two years.
- The provider pharmacy can produce a report of all transactions of the automated dispensing system, including:
- A single drug usage report that complies with R4-23-408(B)(5).
- An authorized user history including the date and time of access and the type of transaction.
- Procedures to safeguard the storage, packaging, and distribution of drugs by monitoring:
- Current inventory.
- Expiration dates.
- Controlled substance dispensing.
- Re-dispense requests.
- Wastage.

Answer 97

A

A: The pharmacy permittee or pharmacist-in-charge must:

Ensure an electronic log is kept for each container fill that includes:
- Identification of the container: Drug name, strength, and container number.
- Manufacturer or NDC number: The drug’s manufacturer or National Drug Code (NDC) number.
- Expiration date and lot number: Expiration date and lot number from the manufacturer’s stock bottle used to fill the container. If multiple lot numbers of the same drug are added to a container, each lot number and expiration date must be documented.
- Date filled: The date the container is filled.
- Identity of the licensee: Documentation of the identity of the licensee who placed the drug into the container.
- Supervising pharmacist: If the licensee who filled the container is not a pharmacist, documentation of the identity of the pharmacist who supervised the non-pharmacist licensee.
Maintain the electronic log for inspection: The log must be available for inspection by the Board or its staff for not less than two years.

Answer 98

A

A: The pharmacy permittee or pharmacist-in-charge must:

Implement an ongoing quality assurance program that monitors the performance of the automated dispensing system and compliance with established policies and procedures, including:
- Training: Training in the use of the automated dispensing system for all authorized users.
- Maintenance and calibration: Maintenance and calibration of the automated dispensing system as recommended by the device manufacturer.
- Accuracy validation testing: Routine accuracy validation testing no less than every three months.
- Downtime and malfunction procedures: Procedures to ensure the timely provision of medication to the long-term care facility resident during downtime and malfunctions.
Maintain documentation: Documentation of maintenance, calibration, and accuracy validation testing must be kept for inspection by the Board or its staff for not less than two years.

Answer 99

A

A: When a new pharmacist-in-charge is appointed, they must:

Complete an inventory of all controlled substances within 10 days of assuming the role.
Ensure the inventory includes:
- An exact count of all Schedule II controlled substances.
- An exact count of all Schedule III through Schedule V controlled substances or an estimated count if the stock container contains fewer than 1001 units.
- The date the inventory is taken and whether it is taken before opening or after closing of business.
Sign the inventory:
- The inventory must be signed by the pharmacist-in-charge, or for other required inventories, by the pharmacist who conducts the inventory.
Keep the inventory records:
- Separately from all other records.
- Available for inspection by the Board or its designee for not less than three years.

Answer 100

A

The correct answer is ‘A’ ‘B’ ‘D’ ‘F’

Answer 101

A

A pharmacy technician trainee can assist with the following tasks:

Record serial numbers and dispense dates on original prescription orders.
Initiate or accept refill authorizations from medical practitioners or their agents, recording necessary details such as medical practitioner’s name, patient name, medication details, and refill information.
Record information in the refill record or patient profile.
Enter information for new or refill prescriptions as required by law.
Type and affix prescription labels, with verification by a pharmacist or intern.
Reconstitute medications, with ingredients and procedures checked and final products verified by a pharmacist.
Retrieve, count, or pour medications, with contents verified by a pharmacist.
Prepackage drugs according to regulations.
Prepare and package drugs for hospital inpatient dispensing, with accuracy and safety verified by a pharmacist before delivery to patient care areas.

Answer 102

A

In addition to the tasks permitted for a pharmacy technician trainee, a licensed pharmacy technician may:

Perform the tasks listed for a pharmacy technician trainee.
Assist in compounding prescription medications and sterile or nonsterile pharmaceuticals after completing a drug compounding training program, with the final product’s preparation, accuracy, and safety verified by a pharmacist before dispensing.
Perform a final technology-assisted verification of the product if qualified under the specific regulations.
Type and affix prescription medication labels, with label accuracy verified by a pharmacist or intern, particularly if technology-assisted verification is performed.

Answer 103

A

A pharmacy technician or pharmacy technician trainee is prohibited from performing any professional practices that are reserved for a pharmacist, graduate intern, or pharmacy intern, in accordance with R4-23-402 or R4-23-653.

Answer 104

A

Requirements:
- The prescription order must include the prescriber’s name, address, and federal registration number.
- For Schedule II controlled substances (other than hospital inpatient orders), only one drug order is allowed per prescription blank.
Restrictions:
- Changes to a written or electronic Schedule II controlled substance prescription order can be made by the pharmacist only if authorized verbally by the prescriber, except for:
  1. The patient’s name.
  2. The prescriber’s name.
  3. The drug name.
Documentation:
- The pharmacist must document the changes made on the original prescription order, including the time and date the authorization was granted.

Answer 105

A

Prescription Order Requirements:
- Must have a written, oral, or electronic prescription order from a medical practitioner, except when dispensed directly by a medical practitioner to the ultimate user.
- The prescription order cannot be filled or refilled more than six months after the issue date.
- Refills are limited to a maximum of five times.

Additional Quantities:
- Any additional quantities must be authorized by a new prescription order from the prescribing medical practitioner, which will be treated as a new and separate prescription order by the pharmacist.

Answer 106

A

Prescription Order Requirements:
- Must have a written or oral prescription order from a medical practitioner, except when dispensed directly by a medical practitioner to the ultimate user.

Refill Regulations:
- The prescription order can be refilled as authorized by the prescribing medical practitioner.
- The prescription order cannot be filled or refilled more than one year after the date of issuance.

Answer 107

A

Ordered by the prescriber not to be refilled.
More than one year since it was originally ordered.

Answer 108

A

A health professional authorized to prescribe controlled substances must limit the initial prescription of a Schedule II opioid to a maximum of a five-day supply.
- An exception is made for initial prescriptions following a surgical procedure, which may be for up to a fourteen-day supply.

Answer 109

A

Has an active oncology diagnosis.
Has a traumatic injury, not including a surgical procedure.
Is receiving hospice care.
Is receiving end-of-life care.
Is receiving palliative care.
Is receiving skilled nursing facility care.
Is receiving treatment for burns.
Is receiving medication-assisted treatment for a substance use disorder.
Is an infant who is being weaned off opioids at the time of hospital discharge.

Answer 110

A

Prescription Deemed Exempt:
- An initial prescription for a Schedule II opioid written for more than a five-day supply is considered to meet exemption requirements when presented to the dispenser.
.
Pharmacist’s Responsibility:
- The pharmacist is not required to verify with the prescriber whether the initial prescription complies with this section.

Answer 111

A

A pharmacist licensed under this chapter can prescribe and dispense tobacco cessation drug therapies to a qualified patient.
Prescriptive authority is limited to nicotine-replacement tobacco cessation drug therapies, which include both prescription and nonprescription therapies.

Answer 112

A

A pharmacist must successfully complete a course of training accredited by the Accreditation Council for Pharmacy Education (ACPE) in tobacco cessation.
The pharmacist must also complete two hours of ACPE-accredited tobacco cessation continuing education programs upon license renewal.
The training course must include the following topics:
1. Epidemiology and health consequences of tobacco-containing products.
2. Biological, psychological, and sociocultural components of tobacco dependence.
3. Assessment of a patient’s willingness to quit.
4. Development of a quit plan.
5. Relapse prevention strategies.
6. Approved medications for nicotine addiction and the effectiveness of current drug therapies for smoking cessation.
7. Nonpharmacological and behavioral interventions.

Answer 113

A

Notify the qualified patient’s designated primary care provider within seventy-two hours after the medication is prescribed.
Keep records that include the qualified patient’s initial assessment information, the education provided and the medication plan, and any drug therapies prescribed. The records shall be made available to the qualified patient’s designated primary care provider on request.

Answer 114

A

Is at least eighteen years of age.
Is enrolled in a structured tobacco cessation program consisting of an initial evaluation and appropriate follow-up visits with the pharmacist or primary care provider if prescribing a prescription nicotine replacement.
Has been educated on symptoms of nicotine toxicity and when to seek medical treatment.

Answer 115

A

The BUD is the date after which a compounded preparation should not be used, starting from the date the preparation is compounded.
The expiration date of the manufactured product cannot solely determine the BUD for the compounded preparation.
The compounder must consult the manufacturer for stability information and relevant literature for stability, compatibility, and degradation of ingredients.
Excessive chemical degradation and drug concentration loss due to reactions might be invisible, hence the importance of thorough stability data.
This is per United States Pharmacopeia (USP) Chapter 795.

Answer 116

A

Every pharmacy that dispenses a controlled substance must be registered with the DEA (21 U.S.C. 823(f) and 21 CFR 1301.11(a)).
Pharmacy registrations must be renewed every three years using DEA Form 224a.
Handling controlled substances under an expired registration is prohibited, even if reinstated within the calendar month after expiration.
Under 21 U.S.C. 824(a), the DEA can suspend or revoke a registration if the registrant:
1. Has materially falsified the application;
2. Has been convicted of a felony related to a controlled substance or a List I chemical;
3. Has had a state license or registration suspended, revoked, or denied by a competent state authority and is no longer authorized to engage in the manufacturing, distribution, or dispensing of controlled substances or List I chemicals, or has had such actions recommended by a competent state authority;
4. Has committed acts rendering the registration inconsistent with the public interest as determined under 21 U.S.C. 823(f);
5. Has been excluded from participating in a program under 42 U.S.C. 1320a-7(a).

Answer 117

A

If a pharmacy goes out of business or is acquired by a new pharmacy, it may transfer the controlled substances to another pharmacy.
On the day the controlled substances are transferred, a complete inventory must be taken. This inventory must document:
1. Drug name
2. Dosage form
3. Drug strength
4. Quantity
5. Date transferred
DEA Form 222 or the electronic equivalent must be prepared to document the transfer of Schedule II controlled substances.

Answer 118

A

The correct answer is ‘A’ ‘B’ ‘C’ ‘D’ ‘E’ ‘F’ ‘H’ ‘I’ (basically everything but the BBW!)

Answer 119

A

Determine the patient is at least 18 years old;
Obtain from the patient a completed self-screening risk assessment based on nationally recognized guidelines;
Provide the patient with written information prepared by the manufacturer of the hormonal contraceptive; and
Provide the following information orally to the patient:

a. How hormonal contraception works;

b. When and how to take the self-administered hormonal contraceptive;

c. Risks associated with taking a self-administered hormonal contraceptive; and

d. When to seek medical assistance while taking a self-administered hormonal contraceptive.

B. A pharmacist who dispenses a self-administered hormonal contraceptive under a standing prescription order shall have a patient complete the self-screening risk assessment based on nationally recognized guidelines, required under subsection (A)(2), annually.

Brainscape's Knowledge GenomeTM

PharmLaw Set #2 (AZ) Flashcards

Brainscape's Knowledge Genome^TM