Texas MPJE 2023: Dr. C's Review Chapter 7

Class C: a facility with _____ beds or more shall be under continuous on-site supervision of a pharmacist when the pharmacy department is open for services.

101 beds

Class C: a facility with ____ beds or fewer shall have the services of a pharmacist at least part time or on a consulting basis, but the pharmacist must be on-site at least once every ____ days.

1. 100 beds

2. every 7 days

Class C: if an institution operates an outpatient pharmacy, there must be a _____________ on-site when the outpatient pharmacy is open. The outpatient pharmacy must also meet all ____________ rules, including the pharmacy tech-to-pharmacist ratio.

1. pharmacist

2. Class A (community)

Class C: facilities with ______ beds or more must have one full-time PIC who can only be PIC for one such facility. This PIC may not serve as a PIC for a Class ___ or ____ pharmacy.

1. 101 beds

2. Class A or B pharmacy

Class C: Facilities with _____ beds or fewer must have a PIC who may be employed or under contract as a consultant and may be part time. One pharmacist may be PIC of no more than ____ such facilities or _____ beds.

1. 100 beds or fewer

2. no more than 3 such facilities or 150 beds

*may be a PIC of one facility with 101 beds or more and one facility with 100 beds or fewer as long as the total number of beds does not exceed 150.

Class C PIC Responsibilities

1. assuring the legal operation of the pharmacy

2. providing the appropriate level of pharmaceutical care services

3. ensuring drugs and/or devices are prepared and distributed safely and accurately as prescribed

4. participating in development of a formulary for the facility

5. supervising a system to ensure maintenance of effective controls against prescription drug diversion

Class C Pharmacist Responsibilities

1. responsible for delegated acts performed by techs and trainees

2. distributing pharmacist (checks meds prior to distribution) is responsible for ensuring that the drug is prepared for distribution safely and accurately as prescribed, unless the pharmacy's computer system can record and identify each pharmacist involved in the preparation process (DRR, data entry verification, preparation, distribution, labeling)

In Class C facilities with 101 beds or more, what duties may technicians perform under physically present pharmacist supervision?

1. pre-packaging and labeling unit-dose and multiple-dose packages

2. preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders

3. compounding nonsterile pharmaceuticals after appropriate training

4. compounding sterile pharmaceuticals after appropriate training (Class C-S only)

5. bulk compounding or batch preparation

6. distributing routine orders for stock supplies to patient care areas

7. entering medication orders and drug distribution information into a computer system

8. loading unlabeled drugs into an automated compounding or counting device

9. accessed automated medication supply systems

In Class C facilities with 100 beds or fewer, what duties may technicians perform under physically present pharmacist supervision?

1. pre-packaging and labeling unit-dose and multiple dose packages

2. bulk compounding or batch preparation

3. loading unlabeled drugs into an automated compounding or drug dispensing system

4. compounding medium-risk and high-risk sterile preparations after appropriate training (Class C-S only)

In Class C facilities with 100 beds or fewer, what duties may technicians perform under physically present or electronic pharmacist supervision?

1. preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders

2. distributing routine orders for stock supplies to patient care areas

3. entering medication orders and drug distribution information into a computer system

4. accessing automated supply systems

5. compounding nonsterile preparations

6. compounding low-risk sterile preparations after appropriate training (Class C-S only)

True or False: there is no ratio of pharmacists to technicians in a Class C pharmacy

True

Tech-Check-Tech

A class C pharmacy that has an ongoing clinical pharmacy program may allow a technician (not a trainee) to verify the work of another tech related to filling of floor stock and unit dose distribution systems if the patient's orders have been previously reviewed by a pharmacist.

Class C Rural Hospitals

75 beds or fewer and located in a county with a population fewer than 50,000 or designated as a critical access hospital, rural referral center, or sole community hospital

If a practitioner orders a prescription drug or device for a patient in a rural hospital when the pharmacist is not on duty or when the pharmacy is closed, a ____________ or ______________ may withdraw the drug from the pharmacy in sufficient quantity to fulfill the order; the hospital pharmacist must verify the withdrawal and perform a DRR no later than ____ day(s) after the withdrawal.

1. nurse or practitioner

2. 7 days

In a rural hospital when a pharmacist is not on duty, technicians, but not trainees, may perform what duties without direct supervision of a pharmacist?

1. entering medication orders and drug distribution information into a computer system

2. preparing, packaging, labeling prescription drugs pursuant to medication orders if a nurse or practitioner (or pharmacist by electronic supervision) verifies the accuracy of the order before administration of the drug to the patient

3. Filing medication carts used in the rural hospital

4. Distributing routine orders for stock supplies to patient care areas

5. Accessing and restocking automated medication supply cabinets

**a nurse or practitioner at the hospital or a pharmacist through electronic supervision must verify the accuracy of the tech performing these duties

Absence of a Pharmacist: What is done in Class C facilities with a full-time pharmacist when the pharmacy is closed?

1. a designated licensed nurse or practitioner may remove drugs for the patient's immediate therapeutic needs

2. a record of the withdrawal must be made containing name of patient, name/strength/dosage form of device or drug, dose prescribed, quantity taken, time and date taken, signature

3. a pharmacist must verify withdrawal as soon as possible but no more than 72 hours after withdrawal

Absence of a Pharmacist: What is done in Class C facilities with a part-time or consultant pharmacist when the pharmacy is closed?

1. a designated licensed nurse or practitioner may remove drugs and devices for the patient's immediate therapeutic needs

2. a pharmacist shall verify the withdrawal of the drugs from the pharmacy after a reasonable interval but in no event may the interval exceed 7 days

3. the pharmacist shall perform a DRR within 96 hours if the facility has an average daily census above 10 and within 7 days if the census is 10 or fewer

4. if using a floor stock system of distribution, the same rules apply, and the pharmacist must verify withdrawal no later than 7 days after withdrawal

Class C Library Requirements (electronic or hard copy)

1. current copies of Texas Pharmacy Act and rules, Texas Dangerous Drug Act and rules, Texas Controlled Substances Act and rules, and Federal Controlled Substances Act and rules

2. drug interaction reference

3. general drug information reference

4. injectable drug products reference

5. basic antidote information and phone number of the nearest regional poison control center

6. metric/apothecary weight and measure conversion chart

Class C Operational Standards

- formulary is required

- prepackaging of drugs is allowed for distribution within the facility or for distribution to other Class C pharmacies under common ownership (specific recordkeeping requirements must be met)

- written policies and procedures of a drug distribution system are required

- DRR must be conducted on a prospective basis when a pharmacist is on duty and on a retrospective basis when not on duty; retrospective review must be conducted within 72 hours if the hospital has a part-time pharmacist, the DRR must be conducted within 96 hours if the facility has an average daily census above 10 and within 7 days if the census is 10 or fewer

- floor stock records must be reviewed by a pharmacist at least every 30 days

- a perpetual inventory of CIIs is required

Class C Emergency Rooms: when a pharmacist is not on duty, dangerous drugs and controlled substances may be supplied to patients admitted to the ER under what conditions?

- only drugs on an ER drug list may be provided

- drugs are supplied in pre-packaged quantities not to exceed a 72-hour supply

- drugs are prepackaged by the pharmacy department, and at the time of delivery the label is completed by the practitioner or nurse with: name/address/telephone of facility, date supplied, name of practitioner, name of patient, directions for use, unique identification number (Rx#), brand name or generic name and strength of the drug used, quantity supplied

- pharmacist shall verify the contents of the ER drug list records at least once every 7 days

Class C Automated Compounding and Counting Devices

- must be calibrated and tested for accuracy

- may be loaded by a tech but must be verified by a pharmacist prior to use

Class C Automated Medication Supply Systems

- include robotic systems and nursing unit-based storage systems such as Pyxis

- must be tested and verified for accuracy

- must operate according to a written QoA program which requires continuous monitoring and tests accuracy at least every 6 months or when an upgrade or change is made to the system

- must operate under written policies and procedures

- may be restocked by a tech provided the medication has been checked by a pharmacist prior to restocking or the system uses machine-readable product identifiers such as barcodes

- pharmacy must have a written plan for recovery from a disaster or other situation that disrupts the automated system

All Class C records must be maintained for ___ year(s) and must be supplied within ____ hour(s) upon request.

1. 2 years

2. 72 hours

True or False: a perpetual inventory is only required for CIIs in a Class C pharmacy

True

*must be maintained separately from other records

True or False: Class C outpatient pharmacy records must be maintained under Class A rules

True

Computer systems for Class C pharmacies must be able to produce a hard copy printout of an audit trail of all drugs distributed in the facility, including what information?

patient's name and room number or identification number, prescribing physician, drug name, strength, dosage form, quantity

*** any audit trail requested must be provided within 72 hours

If the facility has a full-time pharmacist, drugs withdrawn from a Class C-ASC pharmacy must be reviewed by a pharmacist within _____ hour(s) for controls and at a reasonable interval but at least once per _____________ for dangerous drugs.

1. 72 hours

2. once per calendar week

If the facility has a part-time or consultant pharmacist, drugs withdrawn from a Class C-ASC pharmacy shall be verified by the pharmacist at a reasonable interval, but must occur at least once every ____________ the pharmacy is open.

once every calendar week the pharmacy is open.

True or False: Class C-ASC pharmacies must maintain a perpetual inventory of all controlled substances.

True

Invoices of dangerous drugs and controlled substances in a Class C-ASC pharmacy must be dated and initialed by _______________________, and a ________________ must verify that the controls were entered into the perpetual inventory with their ____________.

1. person receiving the drugs

2. pharmacist

3. initials

In a Class C-ASC pharmacy, a pharmacist must conduct an audit by randomly comparing the distribution records with the medication orders at least every _____ day(s).

every 30 days

Class C-ASC pharmacies: who may only be supplied postoperative drugs?

patients admitted to the ASC from the approved drug list

Class C-ASC pharmacies: drugs may only be supplied in prepackaged quantities not to exceed a ____-hour supply.

72-hour supply

Class B (Nuclear) Pharmacies are also regulated by who?

the Texas Department of State Health Services through its Radiation Control Program (Radioactive Material License)

Authorized Nuclear Pharmacists Requirements

1. must be a BPS Certified Nuclear Pharmacist; or

2. must complete 700 hours of a structured education program:

- 200 hours of didactic training approved by the TDSHS Radiation Control Program; and

- 500 hours of supervised experience

Class B Nuclear Pharmacist to Technician Ratio

No more than 1:6 as long as the max number of trainees is 3

True or False: For Class B (Nuclear) pharmacies, a policy and procedure manual is required and Federal Department of Transportation (DOT) regulations must be met.

True

Class B Outer Container Labeling Requirements

1. name, address, phone number of pharmacy

2. date dispensed

3. directions for use

4. prescription number

5. name of the patient if known or "for physician use" if the name of the patient is not known

6. radiation symbol

7. the words "Caution---Radioactive Material" or "Danger---Radioactive Material"

8. the name of the radiopharmaceutical or its abbreviation

9. amount of radioactivity in millicuries or microcuries or becquerels and the corresponding time that applies to this activity if different from the requested calibration date and time

10. initials or identification code of the person preparing and the nuclear pharmacist checking the product

11. if a liquid, volume in milliliters

12. requested calibration date and time

13. expiration date and time

Class B (Nuclear) Inner Container Label Requirements

1. Standard radiation symbol

2. "Caution---Radioactive Material" or "Danger---Radioactive Material"

3. Name of radiopharmaceutical or its abbreviation

4. Prescription number

True or False: refills of radioactive prescriptions are not allowed.

True

Class D Clinic Definition

a facility/location other than a physician's office where limited types of dangerous drugs or devices restricted to those listed in and approved for the clinic's formulary are stored, administered, provided, or dispensed only to outpatients of the clinic

Class D License Definition

copy of the Class D pharmacy policy and procedure manual and formulary is required as part of the license application

Class D (Clinic) PIC Responsibilities

- employed or under a written agreement as a consultant to the facility

- may be the PIC for a number of clinics

- continuous supervision (not on-site) of nurses, PAs, and others carrying out pharmacy-related aspects of the provision of drugs

- documented on-site visits

- development of a formulary

Class D (Clinic) Supportive Personnel Responsibilities

responsible for provision of drugs according to written policies and procedures and completion of the drug label

Class D (Clinic) formularies may include what?

- anti-infective drugs

- musculoskeletal drugs

- vitamins

- obstetrical and gynecological drugs

- topical drugs

- serums, toxoids, vaccines

Class D (Clinic) formularies may not include what?

- Nalbuphine (Nubain)

- erectile dysfunction drugs

- controlled substances

Class D (Clinic) Expanded Formulary Definition

- may petition TSBP for an expanded formulary if serving at least 80% indigent patients

- may provide for other drugs based upon the documented objectives of the clinic

What are the additional requirements if using an expanded formulary in a Class D pharmacy?

1. supportive personnel providing drugs must be licensed nurses or practitioners

2. must have policies and procedures for drugs on the formulary that require special monitoring

3. retrospective DRRs of a random sample of clinic patients must be done on a quarterly basis

4. if the pharmacy provides antipsychotic drugs, the therapy must be initiated by a physician of the clinic. A practitioner shall monitor ongoing therapy, and the patient shall be physically examined by a physician at least yearly

Class D Provision of Drugs

1. drugs are prepackaged and labeled with the name and address of the clinic, name and strength of the drug, quantity, lot number and expiration date, directions for use (may be incomplete), and appropriate ancillary labels

2. drugs are provided to patients by designated supportive personnel who complete the label with the patient's name, any information necessary to complete directions of use, date of provision, and practitioner's name

3. patient counseling shall be provided at the time of provision

4. if using an expanded formulary, only licensed nurses or PAs may provide drugs

5. may store and provide samples of dangerous drugs on the clinic's formulary that have been supplied to the clinic's practitioners from a manufacturer

Class D Dispensing of Drugs

dangerous drugs may only be dispensed by a pharmacist in a Class D pharmacy pursuant to a prescription drug order

Class D Supervision

1. PIC, consultant pharmacist, or staff pharmacist must personally visit the clinic at least monthly

2. clinics operated by state or local governments or funded by government sources may petition TSBP for an alternative visitation schedule

Class E Pharmacies Definition

nonresident (not located in Texas) pharmacies whose primary business is to dispense a prescription drug or device under a prescription drug order and deliver the drug or device to patients in Texas, process a prescription drug order for a patient in Texas, or perform another pharmaceutical service as defined by Board rule

*** a mail-order pharmacy that is located in Texas would not have a Class E license; it would be Class A (Class E is only issued to out-of-state pharmacies)

True or False: the PIC of a Class E pharmacy must be a Texas licensed pharmacist.

True

*** individual pharmacists working in the pharmacy do not have a Texas license

Class E (nonresident) pharmacies must be able to provide dispensing records within ____ hour(s) of TSBP request

72 hours

True or False: Class E (nonresident) pharmacies are required to comply with the provisions of TSBP rules.

True, unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located

Class E Patient Counseling

All new drugs require counseling; treated like delivered meds, so may meet counseling requirements by providing written info regarding the prescription drug, along with a statement that a pharmacist is available via a toll-free telephone number for counseling

A Class E pharmacy that compounds sterile products must register with ______ as a Class _____ pharmacy.

1. TSBP

2. E-S

Class F (Freestanding Emergency Medical Care Facility) Pharmacy

- FEMCF is a freestanding facility that is licensed by the Texas Department of State Health Services to provide emergency care to patients

- must have one PIC who is employed or contracted at least on a consulting or part-time basis

In Class F (FEMCF) pharmacies, only individuals authorized by the _______ may enter the pharmacy or have access to storage areas for prescription drugs

PIC

Class F (FEMCF) Absence of Pharmacist

only a designated licensed nurse or practitioner may remove drugs from the pharmacy in sufficient quantities for the immediate therapeutic needs of a patient

In Class F pharmacies with a full-time pharmacist, the pharmacist shall verify the withdrawal of controlled substances from the pharmacy as soon as possible but no more than ____ hour(s) from the time of such withdrawal and at a reasonable interval for dangerous drugs, but at least once in every ____________.

1. 72 hours

2. calendar week

In Class F pharmacies with a part-time or consultant pharmacist, the pharmacist shall verify withdrawals of all drugs at a reasonable interval, but such verification must at once in every ____________ that the pharmacy is open.

every calendar week that the pharmacy is open

A Class F pharmacy must maintain a perpetual inventory of ______________ which shall be verified for completeness and reconciled at least once in every _______________ that the pharmacy is open.

1. all controlled substances

2. every calendar week that the pharmacy is open

For Class F pharmacies, invoices of dangerous drugs and controlled substances must be dated and initialed or signed by _______________________________.

person receiving the drugs

*pharmacist shall verify that the controls listed on the invoices were added to the pharmacy's perpetual inventory by clearly recording their initials and the date of review of the perpetual inventory

For Class F pharmacies, drugs on an approved outpatient drug list may be supplied for outpatient use only in prepackaged quantities not to exceed a ____-hour supply if prelabeled by the pharmacy. At the time of delivery of the drug, the __________________ or _________________________ must complete the label.

1. 72 hour supply

2. practitioner or licensed nurse under the practitioner's supervision

For Class F pharmacies, a ______________ random DRR must be conducted at least every ______ day(s) to verify proper usage of drugs.

1. retrospective

2. every 31 days

Class G (Central Prescription Drug Order or Medication Order Processing)

issued to a facility established for the primary purpose of processing prescription drug or medication drug orders on behalf of another pharmacy, a healthcare provider, or a payor

Class G pharmacies cannot possess, store, or dispense drugs but may perform what actions?

1. Receiving, interpreting, or clarifying prescription drugs or medication drug orders

2. Data entering and transferring of prescription drug or medication order information

3. Performing a DRR

4. Obtaining refill and substitution authorizations

5. Verifying accurate prescription data entry

6. Interpreting clinical data for prior authorization for dispensing

7. Performing therapeutic interventions

8. Providing drug information concerning a patient's prescription

True or False: Class G pharmacies do not have a maximum ratio of pharmacists to technicians

True