Class A Pharmacy Rules Flashcards

You may prefer our related Brainscape-certified flashcards:
1
Q

PIC

A

Each Class A Pharmacy will have ONE PIC who is employed full time
PIC may only be PIC of ONE Class A Pharmacy unless the other is not open at the same time or there is an emergency where the PIC works at least 10 hours in each Pharmacy for no more than 30 days

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2
Q

Owner

A

Responsibility for all administrative and operational functions
Must consult with PIC on another pharmacist for establishing policies and procedures

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3
Q

Pharmacist

A

Responsible for supervising pharmacy technicians and trainees

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4
Q

Dispensing Pharmacist

A

Pharmacist who performs the final check
Responsible for ensuring that drugs are dispensed safely and accurately as prescribed unless the system can identify each pharmacist involved in different steps of the dispensing process (otherwise they are responsible for anything that is wrong)

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5
Q

Duties which may only be performed by a pharmacist: **

A
  • Receiving oral prescription drug order and reducing these orders to writing
  • Interpreting Prescription drug orders
  • Selecting drug products
  • Performing final check of a dispensed product
  • Patient counseling
  • assuring that a reasonable effort is made to obtain, record, and maintain patient medication records
  • Interpreting patient medication records and performing drug regimen reviews
  • Verifying the controlled substance is listed on invoices are received by initialing and dating invoices
  • Transferring or receiving a transfer of a prescription
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6
Q

Pharmacy Technician and Trainee Duties

A
  • Initiating and receiving refill authorization request
  • Initiating electronic transfer request between pharmacy sharing a common database
  • Entering prescription doubt it into a computer system
  • Taking a stock bottle from the shelf for prescription. Preparing and packaging prescription drug orders
  • Affixing prescription labels and auxiliary labels to a prescription
  • Reconstituting medications
  • Loading bought drugs into an automated counting or dispensing device provided a pharmacist verified prior to use
  • Bulk compounding
  • Compounding nonsterile prescription drug orders after appropriate training
  • In a class A–S pharmacy, compounding of sterile perforations after proper training
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7
Q

Differences between Technicians and Trainees in Class A Pharmacy

A

None

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8
Q

Environment Standards

A

Orderly and clean
Sink with hot and cold running water, exclusive restrooms
If serving the public, a patient counseling area shall be designed to maintain confidentiality
Appropriate lighting and temperature
No animals
Designated area for flammable material

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9
Q

Security Requirements

A

Must be locked by key, combination, or other mechanical or electronic means to prohibit unauthorized access
May not be duplicated in a key or combination
Must have a basic alarm system with off site monitoring and motion detectors
PIC or owner may authorize individuals to enter prescription department to perform functions other than dispensing but 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
Must have a written policy and procedures for security

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10
Q

Temporary Absence of A Pharmacist - On-site

A

At lease one pharmacy technician remains in the pharmacy
Pharmacist must remain on the premises
A notice must be posted that the pharmacist is on break
During a break, pharmacy technicians may begin processing prescription drug orders or refills, but those orders may not be delivered until the pharmacist returns and verifies the accuracy of the prescription. Any intern on duty may only act as a technician while pharmacist is absent
Patients may pick up prescriptions that have already been filled

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11
Q

Temporary Absence of a Pharmacist - Off Site

A

If the pharmacist leaves the premises of the facility, the prescription Department must be closed and pharmacy technician may not remain in the pharmacy.
If a short period of time does not exceed 2 hours in a 24 hour period, an agent of the pharmacist may deliver a previously verified prescription to a patient
Must maintain a record of the date of delivery, Rx number, patient’s name and phone number, and signature of person picking up the prescription (same requirements for delivered prescriptions)
Automated kiosk for refills may be used when Pharmacist is off site for 2 hours only

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12
Q

Patient Counseling Requirements

A

Mandatory patient Counseling for new prescription drug order
Information provided must be deemed significant by the pharmacist
Verbal and written information must be provided
Must document that counseling occurred but they can refuse
If prescription is delivered, the following statement must accompany the script “Written information has been provided… if you have any questions, a pharmacist is available during business hours at 555-555-5555.”

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13
Q

Refusal of Counseling

A

There is no such thing as an “offer to counsel” in Texas. You have to make it a statement “The pharmacist would like to speak with you about this prescription.” Then they can refuse and you must document it.

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14
Q

Drug Regimen Reviews - At minimum , the pharmacist must review and identify what for a new drug?

A
Known allergies
Rational drug therapy or contraindications
Reasonable dose and route
Duplication of therapy
Drug-drug interactions
Drug-food interactions
Drug-disease interactions
ADRs
Proper utilization (over and under)
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15
Q

15 Labeling Requirements for Dispensed Drugs

A

1) Name, address and phone number of Pharmacy
2) Prescription number
3) Date dispensed
4) Initials or identification code of the dispensing pharmacist
5) name of prescriber
6) Name A pharmacist signing a prescription drug order if applicable
7) Name a patient (if were an animal, the species the name of the owner)
8) Instructions for use
9) Quantity dispensed
10) Appropriate ancillary instructions
11) If for a C2, C3, C4 drug, the federal transfer statement saying law prohibits the transfer of this drug to any other person then who it’s prescribed for (not C5 or Dangerous Drugs)
12) Substituted for brand prescribed or substituted for brand
13) Name and strength of drug dispensed
14) An expiration date that is not greater than one year from date dispensed or manufacturers expiration date
15) Either the prescription label or the written information the company the prescription shall contain the statement do not flush unused medication or pour down a sink or drain

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16
Q

Undelivered Medications***

A

May be returned to pharmacy stock for dispensing. Pharmacist must evaluate quality and safety of the prescriptions
Prescriptions cannot be mixed in with manufacturers containers and must be placed in a new container when dispensed**

17
Q

Equipment Requirements

A

Data processing system computer including a printer.
Refrigerator.
Child resistant, light resistant and if applicable glass tight containers.
Prescriptions, poison, and other applicable label.
Metric apothecary weight and measure conversion chart.
Class A prescription balance is required if the pharmacy compounds prescription drug orders

18
Q

Library Requirements

A

May be either hard copies or electronic
Laws and rules including Texas pharmacy act, dangerous drug act, Texas controlled substance act, and federal controlled substance act
Patient drug information text or leaflets
Drug interaction reference
General drug information reference
Basic antidote information and phone number of the nearest poison control center

19
Q

Customized Patient Medication Packages

A

Pharmacy may with the consent of the patient or the provider, provide a custom patient MedPAC which is a container holding two or more prescribe solid oral dosage forms.
Must have a prescription number for the MedPAC in a separate prescription number for each drug within it.
Must have an expiration date not exceeding one year from the date the spinster the earliest manufacturing expiration date

20
Q

Automated Compounding or Counting Devices Requirements

A

Must be calibrated and verified on a routine basis
Records of loading the device must be maintained
Pharmacist must verify and sign that system is properly loaded prior to use

21
Q

Automated Pharmacy Dispensing System Requirements

A

Must have been tested and found to dispense accurately
Must operate according to a written quality assurance program which requires continuous monitoring and tests accuracy every 6 months
Must operate under written policies and procedures
Must have a recovery plan for disasters
Final check

22
Q

Automated Dispensing System Final Check may be accomplished by: **

A

The pharmacist checking the final product after the automated system has completed the prescription in prior to delivery to the patient
OR
The pharmacist verifying that any bulk, stock drugs have been accurately stocked and the pharmacist check the accuracy of the data entry of each prescription entered into the system. This requires a fully automated system from the time the pharmacist releases the prescription to the system until I complete, labels prescription ready for delivery is produced