PharmLaw Set #2 (AZ) Flashcards

Question

# 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 1

3. 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 4. 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.

Answer 2

1. Approved use for the prescription medication; 2. Possible adverse reactions; 3. Drug-drug, food-drug, or disease-drug interactions; 4. Missed dose information; and 5. 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.

Answer 3

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;

Answer 4

1. Change the prescribed quantity if the prescribed quantity is not a package size commercially available from the manufacturer; 2. Change the prescribed dosage form or directions for use if the change achieves the intent of the prescribing medical practitioner; 3. Complete missing information on the prescription order if there is sufficient evidence to support the change; and 4. 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 :)

Answer 5

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

Answer 6

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.

Answer 7

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

Answer 8

- 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.

Answer 9

- 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.

Answer 10

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

Answer 11

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.

Answer 12

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.

Answer 13

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.

Answer 14

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.

Answer 15

- 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.

Answer 16

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;

Answer 17

1. Review the policies and procedures biennially and revise them if necessary. 2. Document the biennial review of the policies and procedures. 3. Assemble the policies and procedures into a written manual or by another method approved by the Board or its designee. 4. Make the policies and procedures available within the pharmacy for reference by pharmacy personnel. 5. Ensure the policies and procedures are accessible for inspection by the Board or its designee.

Answer 18

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.

Answer 19

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.

Answer 20

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.

Answer 21

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.

Answer 22

1. 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 2. After a prescription order is dispensed, any alteration of prescription order information is documented, including the identification of the pharmacist responsible for the alteration.

Answer 23

1. The computer system was in use in the pharmacy before July 11, 2001, and 2. The pharmacy complies with the manual recordkeeping requirements of R4-23-402 and R4-23-407.

Answer 24

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).

Answer 25

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.

Answer 26

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.

Answer 27

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.

Answer 28

1. 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. 2. Immunizations or vaccines to any person regardless of age during a public health emergency response of this state pursuant to section 36-787.

Answer 29

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.

Answer 30

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.

Answer 31

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.

Answer 32

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.

Answer 33

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.

Answer 34

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. 2. **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.

Answer 35

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. 2. **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.

Answer 36

1. **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 2. **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.

Answer 37

1. **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. 2. **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 38

1. **Transfer to Pharmacy Area:** - Prescription-only drugs and controlled substances received outside the pharmacy area must be immediately transferred, unopened, to the pharmacy area. 2. **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 39

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 40

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 41

**The notice must include:** 1. The name, address, pharmacy permit number, and D.E.A. registration number of the pharmacy discontinuing business. 2. 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. 3. 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. 4. 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. 5. The proposed date of discontinuing business operations.

Answer 42

**The following actions must be completed:** 1. **Remove Signs and Symbols:** Ensure that all pharmacy signs and symbols are removed from both the inside and outside of the premises. 2. **Return Permits and Certificates:** Return all state permits and certificates of registration to the Board office. 3. **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 43

**The licensee, permittee, or registrant must:** 1. **Contact a Reverse Distributor:** Reach out to a D.E.A.-registered reverse distributor for the proper destruction of outdated or damaged controlled substances. 2. **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 44

**During the three-year record retention period specified in subsection (A)(3), the person responsible for the discontinued pharmacy’s records must:** 1. **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 45

**The pharmacist-in-charge must ensure the following:** 1. **Access to Drugs:** Only a pharmacist has access to prescription-only drugs and controlled substances until they are transferred. 2. **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. 3. **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 46

**During the seven-year record retention period specified in subsection (A)(4), the person responsible for the discontinued pharmacy’s records must:** 1. **Provide Records to the Board:** Furnish the Board with records of prescription files and patient profiles upon request.

Answer 47

A pharmacy permittee or pharmacist-in-charge must ensure that a mechanical storage and counting device complies with the following: 1. **Identification of Contents:** - The drug name and strength are affixed to the front of each cell or cassette. 2. **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. 3. **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 48

A pharmacy permittee or pharmacist-in-charge must ensure the following: 1. **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). 2. **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 49

The pharmacy permittee or pharmacist-in-charge must ensure the following: 1. **Training:** - Document training in the maintenance, calibration, and use of the mechanical storage and counting device for each employee who uses the device. 2. **Maintenance and Calibration:** - Perform maintenance and calibration of the device as recommended by the manufacturer. 3. **Quality Assurance:** - Conduct routine quality assurance and accuracy validation testing for each mechanical storage and counting device.

Answer 50

**The pharmacy permittee or pharmacist-in-charge must:** 1. **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. 2. **Biennial Review:** - Review the policies and procedures biennially and revise them if necessary. 3. **Document Review:** - Document the biennial review of the policies and procedures. 4. **Assemble Manual:** - Assemble the policies and procedures into a written or electronic manual. 5. **Availability:** - Make the policies and procedures available within the pharmacy for employee reference and inspection by the Board or its staff.

Answer 51

1. **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. 2. **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. 3. **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. 4. **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. 5. **Regulatory Oversight:** - The Board’s oversight is limited to inspecting the pharmacy’s CQA policies and procedures and enforcing compliance. 6. **Mitigating Factor:** - Compliance with the CQA program may be considered a mitigating factor in the investigation and evaluation of medication errors.

Answer 52

1. **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. 2. **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. 3. **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. 4. **Drug Compounding:** - Compound, admix, combine, or prepare drugs for dispensing. Pharmacy technicians may do so under pharmacist supervision according to approved policies. 5. **Verification of Technician Work:** - Verify the accuracy and safety of drugs prepared by pharmacy technicians or trainees, including procedures and compliance with policies. 6. **Drug Repackaging:** - Supervise drug repackaging and check the completed product as specified. 7. **Training and Education:** - Supervise training in aseptic technique and drug incompatibilities for personnel involved in parenteral product admixture. 8. **Consultation:** - Consult with medical practitioners about patient drug therapy or medical conditions. 9. **Patient Consultation:** - Provide consultation regarding medication orders, patient profiles, or drug therapy when requested or deemed necessary. 10. **Drug Therapy Monitoring:** - Monitor patient drug therapy for safety and effectiveness. 11. **Drug Information:** - Provide drug information to patients and healthcare professionals. 12. **Personnel Management:** - Manage pharmacy technicians and other personnel to ensure accuracy, safety, and risk-free operations. 13. **Medication Order Accuracy:** - Verify the accuracy of all aspects of the medication order. 14. **Quality Assurance Compliance:** - Ensure pharmacy personnel comply with the hospital’s quality assurance program.

Answer 53

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 54

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 55

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 56

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 57

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 58

1. 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 2. 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 59

1. Specifically ordered by a medical practitioner, and 2. The patient is educated and trained in the proper manner of self-administration.

Answer 60

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: 1. **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. 2. **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 61

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 62

**Compounding Sterile Pharmaceutical Products: Key Requirements** 1. **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. 2. **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. 3. **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 63

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 64

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 65

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

Answer 66

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

Answer 67

1. Develop and maintain an inventory listing of the drugs to be included in a remote drug storage area; and 2. 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 68

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: 1. 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. 2. 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. 3. Within four hours after the pharmacist returns, they must verify all records of drug removal that occurred during their absence.

Answer 69

1. 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. 2. 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. 3. Only a pharmacist from the dispensing pharmacy can relabel or alter an illegible or missing prescription medication label. 4. 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. 5. Drugs previously dispensed to a resident by another pharmacy or previously dispensed by the provider pharmacy are not to be repackaged.

Answer 70

**Emergency Drug Supply Unit Policies and Procedures for Long-Term Care Facilities** 1. **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). 2. **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. 3. **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** 4. **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. 5. **Education:** Educate pharmacy and long-term care facility personnel on the storage and use of the emergency drug supply unit.

Answer 71

**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 72

**A: The pharmacy permittee or pharmacist-in-charge must:** 1. **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. 2. **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 73

**A: The pharmacy permittee or pharmacist-in-charge must:** 1. **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. 2. **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 74

**A: When a new pharmacist-in-charge is appointed, they must:** 1. **Complete an inventory of all controlled substances within 10 days of assuming the role.** 2. **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. 3. **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. 4. **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 75

The correct answer is 'A' 'B' 'D' 'F'

Answer 76

A pharmacy technician trainee can assist with the following tasks: 1. Record serial numbers and dispense dates on original prescription orders. 2. 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. 3. Record information in the refill record or patient profile. 4. Enter information for new or refill prescriptions as required by law. 5. Type and affix prescription labels, with verification by a pharmacist or intern. 6. Reconstitute medications, with ingredients and procedures checked and final products verified by a pharmacist. 7. Retrieve, count, or pour medications, with contents verified by a pharmacist. 8. Prepackage drugs according to regulations. 9. Prepare and package drugs for hospital inpatient dispensing, with accuracy and safety verified by a pharmacist before delivery to patient care areas.

Answer 77

In addition to the tasks permitted for a pharmacy technician trainee, a licensed pharmacy technician may: 1. Perform the tasks listed for a pharmacy technician trainee. 2. 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. 3. Perform a final technology-assisted verification of the product if qualified under the specific regulations. 4. Type and affix prescription medication labels, with label accuracy verified by a pharmacist or intern, particularly if technology-assisted verification is performed.

Answer 78

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 79

- **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 80

**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 81

**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 82

1. Ordered by the prescriber not to be refilled. 2. More than one year since it was originally ordered.

Answer 83

- 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 84

1. Has an active oncology diagnosis. 2. Has a traumatic injury, not including a surgical procedure. 3. Is receiving hospice care. 4. Is receiving end-of-life care. 5. Is receiving palliative care. 6. Is receiving skilled nursing facility care. 7. Is receiving treatment for burns. 8. Is receiving medication-assisted treatment for a substance use disorder. 9. Is an infant who is being weaned off opioids at the time of hospital discharge.

Answer 85

**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 86

- 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 87

- 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 88

1. Notify the qualified patient's designated primary care provider within seventy-two hours after the medication is prescribed. 2. 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 89

1. Is at least eighteen years of age. 2. 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. 3. Has been educated on symptoms of nicotine toxicity and when to seek medical treatment.

Answer 90

- 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 91

- 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 92

- 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 93

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

Answer 94

1. Determine the patient is at least 18 years old; 2. Obtain from the patient a completed self-screening risk assessment based on nationally recognized guidelines; 3. Provide the patient with written information prepared by the manufacturer of the hormonal contraceptive; and 4. 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.