PharmLaw Set #4 (AZ) Flashcards

Question

**Q: What education must a pharmacist or pharmacy intern provide when dispensing an opioid antagonist under A.R.S. § 32-1979?**

Answer 1

When dispensing an opioid antagonist, the following education must be provided: 1. **Prevention**: - How to prevent an opioid-related overdose. 2. **Recognition**: - How to recognize an opioid-related overdose. 3. **Administration**: - How to safely administer an opioid antagonist to someone experiencing an opioid-related overdose. 4. **Precautions**: - Potential side effects. - Possible adverse events associated with the administration of the opioid antagonist. 5. **Emergency Assistance**: - The importance of seeking emergency medical assistance for the individual experiencing an opioid-related overdose, both before and after administering the opioid antagonist.

Answer 2

- **Authority to Dispense**: - A pharmacist can dispense naloxone hydrochloride or any FDA-approved opioid antagonist. - **Conditions**: - Dispensing must be done pursuant to a standing order issued under A.R.S. § 36-2266. - The dispensing must follow protocols adopted by the board. - **Recipients**: - The opioid antagonist can be dispensed to: - A person at risk of experiencing an opioid-related overdose. - A family member or community member who can assist the person at risk.

Answer 3

1. Document the dispensing consistent with board rules. 2. Instruct the individual to whom the opioid antagonist is dispensed to summon emergency services as soon as practicable after administering the opioid antagonist.

Answer 4

1. The drug is in its original, manufacturer’s, unopened container; and 2. The drug or its container has not been subjected to contamination or deterioration.

Answer 5

1. A hospital inpatient; or 2. A resident of a long-term care facility where a licensed health care professional administers the drug, and the pharmacist ensures and documents that the drug: a. Has been stored in compliance with the requirements of the official compendium; and b. Is not obviously contaminated or deteriorated.

Answer 6

1. The device is inspected and is free of defects; 2. The device is rendered incapable of transferring disease; and 3. The device, if resold or reused, is not claimed to be new or unused.

Answer 7

1. **Current License**: - Must have a current license to practice pharmacy in the state of AZ. 2. **Training Program**: - Successfully complete a Board-approved training program on immunizations 3. **CPR Certification**: - Must have a current certificate in basic cardiopulmonary resuscitation (CPR).

Answer 8

1. **Emergency Oral Prescription**: - In emergencies, a pharmacist can dispense Schedule II controlled substances based on an oral prescription from a medical practitioner. - The oral prescription must be immediately written down by the pharmacist and include all required information except for the manual signature of the practitioner. 2. **Written Prescription Requirement**: - Within seven days, the prescribing medical practitioner must deliver a written prescription manually signed or an electronic prescription order to the dispensing pharmacist. - The prescription must indicate "authorization for emergency dispensing" and the date of the oral order. 3. **Pharmacist’s Responsibility**: - If the written or electronic prescription is not received within seven days, the pharmacist must notify the board. - Failure to notify the board within this timeframe will void the authority to dispense the emergency prescription without a properly signed order.

Answer 9

1. **General Requirement**: - Before dispensing a Schedule II controlled substance, a pharmacist, pharmacy technician, or pharmacy intern must obtain a patient utilization report from the controlled substances prescription monitoring program's central database tracking system for the preceding twelve months at the beginning of each new course of treatment. 2. **Exceptions**: - **Hospice or Palliative Care**: The patient is receiving hospice or palliative care for a serious or chronic illness. - **Cancer or Dialysis**: The patient is receiving care for cancer, a cancer-related illness, or dialysis treatment. - **Medical Practitioner Administration**: A medical practitioner will administer the controlled substance. - **Inpatient or Residential Treatment**: The patient is receiving the controlled substance during inpatient or residential treatment in a hospital, nursing care facility, assisted living facility, correctional facility, or mental health facility. - **Short-Term Prescription**: The controlled substance is prescribed for not more than a five-day period for: - An invasive medical or dental procedure, or - A patient who has suffered an acute injury or medical or dental disease process diagnosed in an emergency department setting that results in acute pain (excluding back pain).

Answer 10

1. **Permit Requirement**: - A pharmacy must have a current Board-issued pharmacy permit to operate in Arizona. 2. **Application Process**: - **Submission**: Submit a completed application form and fee (specified in R4-23-205). - **Approval**: The Board must receive and approve the completed permit application and a satisfactory compliance inspection report. - **Interview**: The Board may interview the applicant and the pharmacist-in-charge if additional information is needed. 3. **Notification**: - Notify the Board within **10 days** of changes to: - Type of pharmacy operated - Telephone or fax number - E-mail or mailing address - Business name - Staff pharmacist - **Provide immediate notice** of a change of pharmacist-in-charge. 4. **Nonprescription Drugs**: - If nonprescription drugs are sold outside the pharmacy area when closed, ensure a current nonprescription drug permit is obtained (see R4-23-603). 6. **Relocation or Remodel**: - **Application**: Submit a completed application for remodel or relocation at least **30 days** prior to the change. No fee is required. - **Inspection**: The new or remodeled facility must pass a final inspection by a Board compliance officer before operations begin.

Answer 11

1. **Minimum Area**: - The primary area devoted to stocking drugs, compounding, and dispensing prescription medications must be at least **300 square feet**. This excludes office and other support areas. 2. **Personnel Capacity**: - Up to **three pharmacy personnel** may work simultaneously in this minimum area **(300 sqft)**. 3. **Additional Space**: - Provide an additional **60 square feet **for each extra pharmacist, graduate intern, pharmacy intern, pharmacy technician, pharmacy technician trainee, or support personnel working simultaneously. 4. **Design Requirements**: - The space must include adequate shelving and be designed for efficient pharmaceutical practice. - The layout should allow free movement and enable visual surveillance of personnel by the pharmacist.

Answer 12

1. **Stock Requirements**: - **Sufficiency**: Maintain a stock sufficient to meet the normal demands of the area or patient base served. - **Standards**: Drugs and chemicals must meet standards of strength and purity as established by official compendiums. 2. **Contamination**: - Ensure all stock, materials, drugs, and chemicals are not contaminated. 3. **Policies and Procedures**: - **Preventive Measures**: Develop and implement policies to prevent: - Sale or use of drugs/chemicals past their expiration date. - Use of deteriorated or damaged drugs/chemicals (due to age, heat, light, moisture, etc.). - Sale of improperly labeled drugs/chemicals. - Use of drugs/chemicals with defective containers. - Use of drugs/chemicals not complying with federal law. - **Availability**: Make policies and procedures available in the pharmacy for employee reference and inspection by the Board. - **Reviews and Quarantine**: - Review expiration-dated drugs/chemicals regularly. - Move expired, deteriorated, damaged, improperly labeled, or non-compliant drugs/chemicals to a quarantine area. - Ensure quarantined items are either properly destroyed or returned to their source of supply.

Answer 13

1. **Compliance**: - Ensure that the automated storage and distribution system, along with the policies and procedures, comply with the relevant regulations. 2. **Notification**: - Notify the Board in writing of the intent to use the automated system, including the type or name of the system.

Answer 14

1. **System Maintenance and Security**: - Ensure the system is in good working order with appropriate recordkeeping and security safeguards. 2. **Patient Access**: - **Prescription Requirements**: - Only contain prescriptions that do not require oral consultation (as specified in R4-23-402(B)). - Ensure prescriptions are properly labeled and verified by a pharmacist before placement and release. - **Patient Choice**: Allow patients to choose whether to use the system. - **Location**: - System must be located in a wall of a properly permitted pharmacy or within 20 feet of the pharmacy, secured to prevent unauthorized removal. - **Patient Identification**: Provide a method to identify the patient and release only their prescriptions. - **Security**: Ensure the system is secure from unauthorized access and removal of drugs or devices. - **Consultation**: Provide a method for patients to obtain a consultation with a pharmacist if requested. - **Counseling Requirement**: Prevent the system from dispensing refilled prescriptions if oral counseling is required. 3. **Authorized Personnel Access**: - **Security**: Ensure the system provides adequate security to prevent unauthorized access to drugs or devices. - **Authorized Handling**: Only authorized licensed personnel may fill, stock, or restock the system. 4. **Quality Assurance**: - Implement an ongoing quality assurance program to monitor compliance with established policies, procedures, and applicable laws.

Answer 15

1. **Preparation and Compliance**: - Ensure that the policies and procedures required under subsection (B) are prepared, implemented, and complied with. 2. **Biennial Review**: - Review the policies and procedures biennially and revise them if necessary. 3. **Documentation**: - Document the biennial review of the policies and procedures. 4. **Manual Assembly**: - Assemble the policies and procedures into a written or electronic manual. 5. **Availability**: - Make the policies and procedures available for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside the pharmacy where the system is used.

Answer 16

1. Training in the maintenance, calibration, and use of the mechanical counting device for each employee who uses the mechanical counting device; 2. Maintenance and calibration of the mechanical counting device as recommended by the device’s manufacturer; and 3. Routine quality assurance and accuracy validation testing for each mechanical counting device.

Answer 17

1. **Record Maintenance**: - **Order Processing**: Maintain manual or electronic records identifying each individual involved in order interpretation, entry, verification, drug utilization review, drug compatibility and allergy review, final verification, therapeutic intervention, or refill authorization. - **Order Filling/Dispensing**: Maintain records identifying each individual involved in filling, dispensing, and counseling functions. 2. **Reporting and Tracking**: - **Disciplinary Actions**: Report to the Board any disciplinary actions taken by other states’ pharmacy regulatory agencies regarding shared services. - **Order Tracking**: Maintain a mechanism for tracking orders throughout the processing and filling procedures. 3. **Security and Inspection**: - **Confidentiality**: Provide adequate security to protect patient information confidentiality and integrity. - **Inspection**: Provide any required records or information to the Board or its designee within 72 hours of request. 4. **Policies and Procedures**: - Develop, implement, review, revise, and comply with joint policies and procedures for shared services, including: - Responsibilities of each pharmacy. - Contact details and license numbers of participating pharmacies. - Policies for: - Notifying patients if their orders are processed or filled by another pharmacy and providing that pharmacy’s name. - Protecting patient information confidentiality and integrity. - Handling situations where the filled order is not received or the patient arrives before the order is received. - Maintaining records of each individual’s activities in shared services. - Compliance with federal and state laws. - Continuous quality improvement for shared services to monitor and improve patient care.

Answer 18

- Confidentiality Controls: The pharmacy must establish controls to protect the confidentiality and integrity of patient information. - Database Protection: No part of the database may be duplicated, downloaded, or removed from the pharmacy’s electronic database.

Answer 19

1. **Personnel Security**: - **Pharmacist Presence**: No one is allowed in the pharmacy unless a pharmacist is present, except as specified in this Section and R4-23-654. If the sole pharmacist must leave the pharmacy for emergencies or patient care, non-pharmacist personnel may remain to perform duties, provided: - C-II controlled substances are secured and accessible only by a pharmacist. - The pharmacist remains available in the hospital. - **Locked Areas**: All hospital pharmacy areas must be kept locked with either a key or programmable lock to prevent unauthorized access. - **Identification Badges**: All pharmacists, pharmacy or graduate interns, pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel must wear identification badges with their name and position whenever on duty. 2. **Prescription Blank Security**: - **Policies and Procedures**: The Director of Pharmacy must develop, implement, review, and revise policies and procedures for the safe distribution and control of prescription blanks that bear the hospital's identification.

Answer 20

1. **Patient Eligibility**: Drugs are dispensed only to patients who have been admitted to the emergency services department. 2. **Authorized Personnel**: Only an authorized medical practitioner can dispense drugs; designees or agents are not permitted to dispense. 3. **Drug Selection**: The nature and type of drugs available are designed to meet the immediate needs of patients treated within the hospital. 4. **Quantity Limits**: Drugs are dispensed in quantities sufficient to meet patient needs until outpatient pharmacy services become available. 5. **Packaging and Labeling**: - Drugs must be prepackaged by a pharmacist, pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist. - Containers must be suitably labeled with drug name, strength, dosage form, quantity, manufacturer, lot number, beyond-use date, and any appropriate auxiliary labels. 6. **Label Completion**: Upon dispensing, the authorized medical practitioner must complete the label on the prescription container in accordance with R4-23-658(D). 7. **Record Keeping**: The hospital pharmacy must maintain a dispensing log, hardcopy prescription, or electronic record approved by the Board or its designee, which includes: - Patient name and address - Drug name, strength, dosage form, quantity - Directions for use - Medical practitioner’s signature or identification code - DEA registration number, if applicable

Answer 21

**Equipment Requirements:** 1. **Environmental Control Devices**: - Must maintain an “ISO class 5 environment” as defined in R4-23-110. - Acceptable devices include laminar airflow hoods, HEPA-filtered zonal airflow devices, glove boxes, pharmaceutical isolators, barrier isolators, and biological safety cabinets. 2. **Disposal Containers**: - For needles, syringes, and other materials used in compounding. - Separate containers for cytotoxic, chemotherapeutic, and infectious waste products if applicable. 3. **Freezer Storage Units**: - Must have thermostatic control and a thermometer if applicable. 4. **Packaging or Delivery Containers**: - Must maintain official compendial drug storage conditions. 5. **Infusion Devices and Accessories**: - If applicable to the compounding process. 6. **Reference Library**: - Must include a current reference pertinent to the preparation of sterile pharmaceutical products in addition to other required references. **Procedures:** 1. **Policies and Procedures**: - Prepare, implement, and comply with written policies and procedures for compounding and dispensing sterile pharmaceutical products. 2. **Review and Revision**: - Review policies and procedures biennially and revise if necessary. - Document the review process. 3. **Documentation**: - Assemble policies and procedures as a written manual or approved method. - Make policies and procedures available for employee reference and inspection by the Board or its designee.

Answer 22

1. The drug is in its original, manufacturer’s, unopened container; and 2. The drug or its container has not been subjected to contamination or deterioration. B. The provisions of subsection (A) of this Section do not apply to a drug dispensed to: 1. A hospital inpatient as defined in R4-23-651; or 2. A resident of a long-term care facility where a licensed health care professional administers the drug, and the pharmacist ensures and documents that the drug: a. Has been stored in compliance with the requirements of the official compendium; and b. Is not obviously contaminated or deteriorated. C. After a person for whom a device is prescribed or the person’s agent takes the device from the premises where sold, distributed, or dispensed, a pharmacist or pharmacy permittee shall not accept the device for return or exchange for the purpose of resale or reuse unless the pharmacist determines that: 1. The device is inspected and is free of defects; 2. The device is rendered incapable of transferring disease; and 3. The device, if resold or reused, is not claimed to be new or unused.

Answer 23

**Assist with Refill Authorizations**: - Initiate or accept verbal or electronic refill authorizations from a medical practitioner or their agent. - Record the following information on the original prescription order or by an alternative approved method: - Medical practitioner's name - Patient's name - Name and quantity of the prescription medication - Specific refill information - Name of the medical practitioner's agent, if applicable **Note**: All tasks must be performed in compliance with applicable statutes and rules, and under the supervision of a pharmacist....They cannot counsel or Accept a new prescription order from a prescriber over the phone

Answer 24

**Disposal Process:** 1. **Request Assistance**: - Submit a **DEA Form 41** to the Special Agent in Charge of the Administration in your area. The form should list the controlled substances you wish to dispose of. 2. **Instructions from the Special Agent in Charge**: - **Transfer**: Move the controlled substances to a registrant authorized to transport or destroy them. - **Delivery**: Deliver the substances to an agent of the Administration or the nearest office of the Administration. - **Destruction**: Destroy the substances in the presence of an agent of the Administration or another authorized person.

Answer 25

1. **Therapeutic Needs:** - Drugs in the unit must meet the immediate and emergency therapeutic needs of residents. - Determined by the provider pharmacy’s pharmacist-in-charge in consultation with the facility’s medical director and nursing director. 2. **Purpose and Responsibility:** - The unit is not a substitute for the provider pharmacy’s responsibility to provide routine drugs. - Its purpose is to ensure immediate access to emergency therapeutic drugs for facility residents. 3. **Packaging and Labeling:** - Drugs must be in a manufacturer’s unit of use package or prepackaged. - Labeling must include: - Drug name - Strength - Dosage form - Manufacturer - Lot number - Expiration date - Provider pharmacy’s name, address, telephone number - Pharmacist’s initials

Answer 26

1. **Notification to the Board:** - The pharmacy permittee or pharmacist-in-charge must notify the Board or its staff in writing of the intent to use the automated unit, including its name and type. 2. **Access Notification:** - The provider pharmacy must be notified electronically whenever the automated emergency drug supply unit is accessed. 3. **Event Recording:** - All access events must be recorded electronically and maintained for at least two years. 4. **Transaction Reporting:** - The provider pharmacy must be capable of producing a report of all transactions and a single drug usage report on inspection by the Board or its staff. 5. **Policies and Procedures:** - Written policies and procedures must be developed for: - Accessing the unit during system malfunctions or downtime. - Authorizing and modifying user access. - An ongoing quality assurance program that includes: - Training all authorized users in the use of the unit. - Maintenance and calibration as recommended by the manufacturer. 6. **Documentation:** - Documentation of the ongoing quality assurance program must be maintained for at least two years for Board inspection.

Answer 27

1. **Notification to the Board:** - The pharmacy permittee or pharmacist-in-charge must notify the Board or its staff in writing of the intent to use the automated dispensing system, including the name and type of the system. 2. **Controlled Substances Registration:** - Obtain a separate controlled substances registration for each long-term care facility location where the system will be used, as required by federal law. 3. **Documentation Maintenance:** - Maintain copies of the controlled substances registrations at the provider pharmacy for inspection by the Board or its staff.

Answer 28

1. **Ownership of Drugs:** - Ensure that drugs in the automated dispensing system remain the property of the provider pharmacy. 2. **Inventory Requirements:** - Include controlled substance drugs in all required inventories, as per A.R.S. § 36-2523(B) and R4-23-1003(A). 3. **Restriction on Schedule II Drugs:** - Ensure that Schedule II drugs are not stocked in the automated dispensing system. 4. **Emergency Drug Supply:** - Provide a separate emergency drug supply unit in the long-term care facility to meet the requirements of R4-23-701.02.

Answer 29

Verify that the assisted living facility has a current and active license issued by the Arizona Department of Health Services.

Answer 30

- Valid Prescription: Ensure the controlled substance prescription drug is dispensed only after receiving a valid prescription order from the resident's medical practitioner. - Labeling: Label the controlled substance prescription drug in accordance with A.R.S. §§ 32-1963.01, 32-1968, and 36-2525, including the beyond-use date.

Answer 31

Prescription Order: Receive a written or oral prescription order from: - The resident’s medical practitioner, - An individual licensed by the Arizona Board of Nursing within their scope of practice, or - The manager or a caregiver of the assisted living facility if authorized by the resident’s medical practitioner.

Answer 32

Prescription Order: 1. Receive a written or oral prescription order from: - The resident’s medical practitioner, - An individual licensed by the Arizona Board of Nursing within their scope of practice, or - An assisted living facility manager or caregiver acting under the authority of a licensed medical practitioner. . 2. Order Verification: Ensure the prescription order meets R4-23-407 requirements and includes the name and title of the individual transmitting the order. . 3. Labeling: Label the non-narcotic prescription or non-prescription drug in accordance with A.R.S. §§ 32-1963.01 and 32-1968, including the beyond-use date.

Answer 33

A pharmacist employed by the pharmacy permittee may relabel the drug container using professional judgment. Only a pharmacist is allowed to label or alter the label of a drug container.

Answer 34

Yes, a pharmacist can help develop written policies and procedures for procuring, administering, storing, controlling, keeping records, and disposing of drugs in the facility and provide information on safe and effective drug self-administration supervision.

Answer 35

No, a pharmacy permittee shall not place an emergency drug supply unit or an automated dispensing system in an assisted living facility.

Answer 36

No, a pharmacist shall not repackage a drug previously dispensed to an assisted living facility resident.

Answer 37

The individual must possess a pharmacy technician or pharmacy technician trainee license issued by the Board.

Answer 38

Be of good moral character. Be at least 18 years of age. Have a high school diploma or the equivalent.

Answer 39

- Meet the requirements for a pharmacy technician trainee. - Complete a pharmacy technician training program that meets the standards prescribed in R4-23-1105. - Pass the Pharmacy Technician Certification Board (PTCB) examination or another Board-approved pharmacy technician examination.

Answer 40

1. For a person practicing as a pharmacy technician out-of-state: Provide proof of current, unrestricted pharmacy technician licensure in another jurisdiction. Provide proof of employment as a pharmacy technician during the last 12 months. . 2. For a person who has not practiced as a pharmacy technician within the last 12 months: Take and pass a Board-approved pharmacy technician examination. Complete 20 contact hours or two CEUs of continuing education, including at least two contact hours or 0.2 CEUs in pharmacy law.

Answer 41

Prepare a written program description including: - Responsibility of the pharmacist in charge and permittee. - Design, implementation, and monitoring of the accuracy and safety process. - Duties and qualifications of a verification technician. - Training requirements for verification technicians. - Monitoring and evaluation procedures for technician competency. - Prohibition of verification technicians performing final accuracy checks.

Answer 42

- Responsibilities of both the pharmacist in charge and permittee. - Process for ensuring product accuracy and safety. - Duties and qualifications of a verification technician. - Necessary training and continuing education for verification technicians. - Procedures for monitoring and evaluating technician competency. - Prohibition of verification technicians from performing final accuracy checks.

Answer 43

- Post the description in the pharmacy area. - Provide a copy to the pharmacist in charge and verification technician. - Obtain and file signed copies from the pharmacist in charge and verification technician. - Ensure scanning technology captures both product and patient information. - Update and repeat the posting and filing process after updates.

Answer 44

- Be licensed under R4-23-1102. - Have at least 1,000 hours of work experience in the same type of pharmacy practice site. - Complete a training program covering: Role and legal requirements of a verification technician. Use of the verification system. Causes of medication errors. Identifying and resolving dispensing errors. - Complete at least four hours of continuing education on patient safety.

Answer 45

- Products with scanning technology that identifies the product. - Robotically prepared unit-dose products. - A Schedule III – V controlled substance

Answer 46

- Products resulting from compounding or mixing ingredients. - Products involving alteration of a drug. - DEA Schedule II controlled substances.

Answer 47

Prescription orders must be kept in a separate prescription file specifically for controlled substances listed in schedules I and II only.

Answer 48

A: - In a separate prescription file specifically for controlled substances listed in schedules III, IV, and V only. - Alternatively, in a form that allows them to be readily retrievable from other prescription records. Definition of "readily retrievable": When initially filed, the prescription must have a red "C" stamped in the lower right corner of the face of the prescription, at least one inch high. The prescription must be filed in the consecutively numbered prescription file for noncontrolled substances. Note: The requirement to stamp the hard copy prescription with a red "C" is waived if an electronic data processing system is used that allows retrieval by prescription number, prescriber's name, patient's name, and drug dispensed.

Answer 49

**A:** 1. **Legitimate Medical Purpose:** The controlled substance must be for a legitimate medical purpose. 2. **Quantity Limits:** - **Opium-containing substances:** No more than 240 cc (8 oz) in any 48-hour period. - **Other substances:** No more than 120 cc (4 oz) in any 48-hour period. - **Dosage units:** - **Opium-containing substances:** No more than 48 dosage units in any 48-hour period. - **Other substances:** No more than 24 dosage units in any 48-hour period. 3. **Ephedrine Preparations:** No more than 100 dosage units of any single active ingredient ephedrine preparation may be sold in a 30-day period. 4. **Identification:** The pharmacist or pharmacy intern must require suitable identification from every purchaser not known to them, including proof of age if appropriate. 5. **Recordkeeping:** A bound record book must be maintained with: - Name and address of the purchaser - Name and quantity of the controlled substance - Date of purchase - Name or initials of the pharmacist or pharmacy intern who dispensed the substance - Compliance with the recordkeeping requirements of section 36-2523.

Answer 50

NONE OF THESE!!! . It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.Unlike drugs, supplements are not permitted to be marketed for the purpose of treating, diagnosing, preventing, or curing diseases. That means supplements should not make disease claims, such as “lowers high cholesterol” or “treats heart disease.” Claims like these cannot be legitimately made for dietary supplements.

Answer 51

90 morphine milligram equivalents per day

Answer 52

Compounding supervisors must ensure that: 1. **Strength Maintenance:** CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% of the labeled strength if not specified, until their Beyond-Use Dates (BUDs). 2. **Verification Method:** This must be verified through either direct measurement or appropriate information sources.

Answer 53

1. **Preparation Conditions:** Hazardous drugs must be prepared in conditions that protect healthcare workers and other personnel. This includes using appropriate chemotherapy gloves during all stages of handling—receiving, distribution, stocking, inventorying, preparation, and disposal. 2. **Storage:** Hazardous drugs should be stored separately from other inventory to prevent contamination and exposure. Preferably, they should be kept in a containment area such as a negative pressure room with sufficient general exhaust ventilation, providing at least 12 air changes per hour (ACPH). 3. **Handling:** Hazardous drugs must be handled with caution using protective measures to minimize risk. 4. **Preparation Environment:** Hazardous drugs must be prepared in an ISO Class 5 environment with appropriate protective engineering controls and aseptic practices, as specified for the relevant contamination risk levels. 5. **Access Control:** Access to areas where hazardous drugs are stored and prepared should be restricted to personnel involved in drug preparation to protect others.

Answer 54

**A:** 1. **Partial Dispensing Conditions:** A Schedule II controlled substance prescription may be partially dispensed if the full quantity cannot be supplied. The pharmacist must: - Note the quantity supplied on the front of the written prescription, on a written record of an emergency oral prescription, or in the electronic prescription record. - Dispense the remaining portion within 72 hours of the first partial dispensing. 2. **Notification and New Prescription:** If the remaining quantity cannot be dispensed within 72 hours, the pharmacist must notify the prescribing practitioner. No further dispensing is allowed beyond 72 hours without a new prescription. 3. **DEA Position:** The pharmacy must have the balance of the prescription ready within 72 hours, but the patient is not required to pick it up within that time frame.

Answer 55

1. **Record Maintenance:** Every retail pharmacy that uses central fill pharmacies must keep records of all central fill pharmacies authorized to fill prescriptions on its behalf. This record must include: - Name - Address - DEA number of each central fill pharmacy. 2. **Verification:** The retail pharmacy must verify the registration of each central fill pharmacy it uses. 3. **Availability for Inspection:** These records must be available for inspection by the DEA upon request.

Answer 56

E! . Here’s a simplified version of the rules for dispensing Schedule II controlled substances: **G. Before Dispensing Schedule II Drugs:** - **Pharmacists, pharmacy technicians, or pharmacy interns** must check a patient’s usage history for the past year from the central database tracking system before starting a new treatment course. **H. Exceptions to Checking the Database:** - **You don’t need to check the database if:** 1. **Hospice or Palliative Care:** The patient is in hospice or receiving palliative care for a serious or chronic illness. 2. **Cancer Care or Dialysis:** The patient is getting treatment for cancer, a related illness, or dialysis. 3. **In-Office Administration:** A medical practitioner will administer the controlled substance directly. 4. **Inpatient Care:** The patient is receiving the substance while in a hospital, nursing home, assisted living facility, correctional facility, or mental health facility. 5. **Short-Term Prescription:** The controlled substance is prescribed for no more than five days for a procedure causing acute pain. 6. **Emergency Prescription:** The controlled substance is prescribed for no more than five days for an acute injury or emergency condition causing acute pain (excluding back pain).

PharmLaw Set #4 (AZ) Flashcards

(83 cards)