Texas MPJE: Dr. C's Review Chapter 6

Each Class A pharmacy shall have _____ PIC(s) who is employed _____________.

1. one

2. full-time

Generally, the PIC may only be a PIC of one Class A pharmacy unless the additional Class is ___________________________.

not open at the same time

During an emergency, the PIC may serve as the PIC for 2 Class A pharmacies open at the same time if they ______________________________________.

work at least 10 hours per week in each pharmacy for no more than 30 consecutive days

Responsibilities of PIC

- legal operation of the pharmacy

- educating and training pharmacy techs

Responsibilities of Owner

- has responsibility for all administrative and operational functions of the pharmacy

- if not a pharmacist, must consult with the PIC or another pharmacist for establishing policies and procedures

True or False: Class A Pharmacists are responsible for supervising pharmacy techs and trainees. Supervision may be done electronically.

True, if the pharmacist has the ability to immediately communicate directly and other conditions are met.

Dispensing Pharmacist definition

- pharmacist who performs the final check

- responsible for ensuring that drugs are dispensed safely and accurately as prescribed unless the pharmacy's computer system can identify each pharmacist involved in different steps of the dispensing process such as DRR, verification of data entry, labeling, etc.

What are the duties which may only be performed by a pharmacist?

1. Receiving verbal prescription drug orders for controlled substances and reducing these orders to writing

2. Interpreting prescription drug orders

3. Selecting drug products (generics)

4. Performing the final check of a dispensed prescription

5. Patient counseling

6. Assuring that a reasonable effort is made to obtain, record, and maintain patient medication records

7. Interpreting patient medication records and performing DRRs

8. Performing DTM under protocol

9. Verifying that controlled substances listed on invoices are received by initialing and dating invoices

10. Transferring or receiving a transfer of a controlled substance prescription

11. Administering immunizations

What may the duties of pharmacy techs and trainees include?

1. Initiating and receiving refill authorization requests

2. Initiating electronic transfer requests between pharmacies sharing a common database

3. Entering prescription data into a computer system

4. Taking a stock bottle from the shelf for a prescription

5. Preparing and packaging prescription drug orders

6. Affixing prescription labels and auxiliary labels to a prescription

7. Reconstituting medications

8. Loading bulk drugs into an automated counting or dispensing device provided by a pharmacist verifies that the device is properly loaded prior to use

9. Loading pre-packaged containers previously verified by a pharmacist or manufacturer's unit-of-use packages into an automated dispensing machine

10. Bulk compounding

11. Compounding nonsterile prescription drug orders after appropriate training

12. In Class A-S, compounding sterile preparations after appropriate training

13. Receiving oral prescription drug orders for dangerous drugs and reducing these orders to writing either manually or electronically

14. Transferring or receiving a transfer or original prescription info for a dangerous drug on behalf of a patient

15. Contacting a prescriber for information regarding an existing prescription

**can receive verbal scripts, transfer scripts, and receive transfer of scripts for dangerous drugs, but not for controlled substances

***13-15 may not be performed by tech trainees

Class A Pharmacy Ratio of On-Site Pharmacists to Technicians and Trainees

1:6 as long as the maximum number of trainees is 3

Class A Operational Standards: Environment

1. orderly and clean

2. sink with hot and cold running water, exclusive of restrooms

3. if the serving the public, a patient counseling area shall be designed to maintain confidentiality

4. appropriate lighting and temperature

5. no animals allowed

6. designated area for flammable materials

Class A Operational Standards: Security (only applies to pharmacies that possess drugs)

1. prescription department must be locked by key, combination, or other mechanical or electronic means to prohibit unauthorized access

2. the pharmacy's key, combination, or means of locking the pharmacy may not be duplicated

3. at minimum, the pharmacy must have a basic alarm system with off-site monitoring and motion detectors

4. PIC or owner may authorize individuals to enter the prescription department to perform functions other than dispensing; However, must maintain written documentation of authorized individuals other than individuals employed by the pharmacy who access the prescription department when a pharmacist is not on site.

5. the pharmacy must have written policies and procedures for security

Class A Operational Standards: Temporary Absence of a Pharmacist and Pharmacist is On-Site (breaks and meals without closing prescription department)

- at least one pharmacy tech (not trainee) remains in the pharmacy

- pharmacist must remain on the premises of the facility

- a notice must be posted that the pharmacist is on break

- during a break, techs may begin processing prescription drug orders or refills; upon return, the pharmacist must conduct a DRR and verify all activities performed.

- any pharmacist intern on duty may only act as a tech while the pharmacist is absent

- patients may pick up scripts that have already been filled and checked by the pharmacist

How can a patient pick up a new prescription where counseling is required if the pharmacist is on break?

treat the prescription the same way you would treat a new prescription that is delivered to the patient at their home; counseling is provided by giving written info about the drug and a notice that the patient can call the pharmacist if the patient has any questions

Class A Operational Standards: Temporary Absence of a Pharmacist and Pharmacist is Off-Site (prescription department is closed)

- if the pharmacist leaves the premises of the facility, the prescription department must be closed, and techs may not remain in the pharmacy; however, this rule allows delivery of filled prescriptions under certain conditions after the pharmacy department has closed

- during short periods of time when a pharmacist is absent, an agent of the pharmacist may deliver a previously verified prescription (new or refill) to a patient in the pharmacy provided periods of time do not exceed 2 consecutive hours in a 24-hour period

*** allows filled scripts to be delivered to patients in the pharmacy for up to 2 hours after the pharmacy department is closed (e.g., grocery stores)

- pharmacy must maintain a record of the date of delivery, prescription number, patient's name and phone number, and signature of person picking up the prescription

*** same for prescription delivered at a patient's residence

- pharmacy may also use an automated dispensing and delivery device to deliver prescriptions; this is not restricted to the 2-hour limitation

Mandatory counseling is required for ______________________________.

new prescription drug orders, which include prescriptions that have not been dispensed to the patient by the pharmacy in the same strength and dosage form within the past year

For patient counseling, verbal and written information must be provided; written information may be electronic (including email) if what?

the patient has requested electronic communication and this request is documented

The pharmacy must document __________ or _________________ of the pharmacist providing counseling either on the _________________ or in the ___________________.

1. initials or identification code

2. prescription or in the computer system

If the prescription is delivered to the patient, the pharmacy must provide what statement about patient counseling in English and Spanish?

"Written information about this prescription has been provided to you. Please read this information before you take the medication. If you have any questions concerning this prescription, a pharmacist is available during normal business hours to answer those questions at (insert phone number)."

Only ________________ may verbally provide drug information to a patient and answer questions concerning prescription drugs.

a pharmacist

**non-pharmacist personnel and/or the computer system may not ask questions of a patient which are intended to screen or limit interaction with the pharmacist

True or False: while a patient may refuse counseling, there is no such thing as an "offer to counsel" in Texas.

True - required for all new prescription drug orders; any refusal of counseling by a patient or their agent must be documented.

True or False: Drug Regimen Reviews (DRRs) are required for all prescriptions (new and refill).

True

For DRRs, the pharmacist, at a minimum, shall review and identify what?

1. known allergies

2. rational therapy-contraindications

3. reasonable dose and route of administration

4. reasonable directions for use

5. duplication of therapy

6. drug-drug interactions

7. drug-food interactions

8. drug-disease interactions

9. adverse drug reactions

10. proper utilization including overutilization and underutilization

Labeling Requirements for Dispensed Prescriptions

1. Name, address, and phone number of the pharmacy

2. Prescription number (easily readable font no smaller than 10-point Times Roman)

3. Date dispensed

4. Initials or identification code of the dispensing pharmacist (not required if maintained in the computer system)

5. Name of prescriber

6. Name of pharmacist signing a prescription drug order (if applicable)

7. Name of patient; if an animal, its species and name of owner

8. Instructions for use (easily readable font no smaller than 10-point Times Roman)

9. Quantity dispensed

10. Appropriate ancillary instructions

11. If for a CII-IV, the federal transfer statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

*** not required for CVs or dangerous drugs

12. "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" if generic substitution has occurred

13. Name and strength of drug dispensed unless otherwise directed by prescriber (easily readable font no smaller than 10-point Times Roman)

14. BUD that is not greater than one year from the date dispensed or the manufacturer's expiration date, whichever is shorter

15. Either the prescription label or the written info accompanying the prescription shall contain the statement: "Do not flush unused medications or pour down a sink or drain."

*** a drug product on a list of medicines developed by the FDA recommended for disposal of flushing is not required to bear this statement

**** these requirements are not required to be met if the drug is for administration to an ultimate user who is institutionalized (hospital, nursing home) and no more than a 90-day supply is dispensed at a time

Notification on Safe Disposal of CIIs

- pharmacy must provide the patient a notification on safe disposal that includes information on locations at which CIIs are accepted for safe disposal

- may alternatively provide an address of an internet website specified by the Board that provides a searchable database of locations at which CIIs are accepted for safe disposal

- written notice may be provided to the patient in an electronic format (email) if the patient or their agent requests the notice in an electronic format and the request is documented

Exemption(s) to Providing the Notification on Safe Disposal of CIIs

- pharmacy that is registered with DEA as an "authorized collector" of controls and regularly accepts controls for safe disposal does not have to provide the notice

- pharmacy that provides to the patient at the time of dispensing and at no cost to the patient either a mail-in pouch for surrendering unused controls or chemicals to render any unused controls unusable or non-retrievable does not have to provide the notice

Returning Undelivered Medication to Stock

1. prescriptions that have not been picked up or delivered may be returned to the pharmacy's stock for dispensing

2. pharmacist must evaluate quality and safety of the returned prescriptions

3. returned prescriptions cannot be mixed in with manufacturer's containers and must be placed in a new container when dispensed unless the prescription is in the manufacturer's original container and the label from the undelivered prescription info is removed to prevent disclosure

Operational Standards: Library (hard copy or electronic)

1. Laws and Rules - 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. At least one current general drug info reference which includes drug interaction information

3. If dispensing vet prescriptions, a general reference on vet drugs

4. Basic antidote information and phone number of the nearest regional poison control center

Customized Patient Medication Packages (Med Paks)

1. a pharmacist may, with consent of the patient or prescriber, provide a customized patient med pak

2. must have a prescription number for the med pak and a separate prescription number for each of the drugs within

3. must have a BUD not exceeding one year from the date dispensed or the earliest manufacturer's expiration for a drug in the med pak

3 Types of Automated Devices and Systems in a Class A Pharmacy

1. Automated Counting Devices

2. Automated Pharmacy Dispensing Systems

3. Automated Checking Device

Automated Counting Devices

- must be calibrated and verified on routine basis

- records of loading the device must be maintained

- pharmacist must verify and sign that the system is properly loaded prior to use

Automated Pharmacy Dispensing Systems

- must operate according to a written QoA program which requires continuous monitoring and tests accuracy at least every 12 months or when an upgrade or change is made to the system

- must have a recovery plan for disasters or other interruptions

- system may be stocked or loaded by a pharmacist or a tech or trainee under pharmacist supervision

- Final check may be accomplished by:

(1) a pharmacist checking the final product after the automated system has completed the prescription and prior to delivery to the patient

(2) a pharmacist verifying that any bulk stock drugs have been accurately stocked, and the pharmacist checks accuracy of data entry of each prescription entered into the system

**** with this method, "final check" is being done prior to the prescription being processed; accuracy tested every month!

Automated Checking Device

A fully automated device which confirms, after dispensing but prior to delivery to the patient, that the correct drug and drug strength have been labeled with the correct label for the correct patient.

True or False: an automated checking device and automated pharmacy dispensing system both can be used to complete the final check of a prescription.

True - ADPS fills the script while checking for accuracy; ACD prescriptions are check for accuracy after dispensing using technology (e.g., barcoding).

All records shall be maintained for _____ year(s)

2 years

__________ records shall be maintained separately from other records

CII records

____________ records, other than prescriptions, shall be maintained separately or be "readily retrievable" from other records.

CIII-V records

Patient Medication Records (required for all new patients)

- must provide for the immediate retrieval of information for the previous 12 months to conduct a DRR

- PIC must assure that a reasonable effort is made to obtain and record at least the following information:

*name, address, and telephone number of patient

*age and gender of patient

*known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states

*other drugs currently being used by the patient

*pharmacist's comments relevant to drug therapy

*a list of all prescription drug orders dispensed (new and refill) to the patient by the pharmacy during the last 2 years

Computer system must be backed up at least __________.

monthly

Computer system must maintain any information (records) purged from computer for ____ year(s) from the date of final entry of data

2 years

Computer system must have capacity to produce a daily hard copy printout consisting of what?

- prescription number

- date of dispensing

- patient name

- prescriber's name

- name and strength of the drug dispensed

- quantity dispensed

- initials or identification code of the dispensing pharmacist

- initials or identification code of pharmacy technician performing data entry, if applicable

- if not immediately retrievable by computer display, must also include patient's address, prescriber's address, prescriber's DEA number if a control, quantity dispensed if different from quantity prescribed, date of issuance of prescription (if different from date of dispensing), and total refills dispensed to date

- any changes made to a record of dispensing

Daily hard copy printout shall be produced within _____ hour(s) of the date the prescriptions were dispensed

72 hours

Each pharmacist who dispensed or refilled a prescription shall verify that the information is correct by signing and dating the hard copy printout within ____ day(s) from the date of dispensing.

7 days

Pharmacy may maintain a daily logbook that pharmacists must sign daily instead of a daily hard copy printout, but the computer system must be able to do what?

produce an "audit trail" within 72 hours

Pharmacies must maintain a log of the unique initials or identification codes which will identify each pharmacist, technician, and trainee who is involved in the dispensing process in the pharmacy's data processing system. This log shall be maintained at the pharmacy for at least ___ year(s) from the date of the transaction

7 years

** only TSBP rule that requires a record to be kept for 7 years

True or False: transfers of prescription drug order information may be communicated verbally or via fax.

True

*techs cannot perform transfers of control scripts

*may be conducted electronically if specific requirements are met

Transfers of controlled substance prescriptions are allowed ____ time(s) unless the pharmacies share an electronic, real-time database.

1 time

True or False: DEA and TSBP rules generally permit a pharmacy to transfer a controlled substance prescription that has been received at a pharmacy but not yet filled at another pharmacy.

False

*** By policy, DEA and TSBP allow a control script to be transferred or forwarded to another pharmacy if the original script was transmitted electronically and it can be forwarded electronically

A prescription that is transferred must be ________ in the computer system

voided (or by writing "void" across the prescription if using a manual recordkeeping system)

An individual may not refuse to transfer a prescription, and transfers must be completed within _____ business hour(s) of a request.

4 business hours

True or False: the electronic transfer of multiple or bulk prescription transfers is permitted.

True