Class A Pharmacy Rules Flashcards
PIC
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
Owner
Responsibility for all administrative and operational functions
Must consult with PIC on another pharmacist for establishing policies and procedures
Pharmacist
Responsible for supervising pharmacy technicians and trainees
Dispensing Pharmacist
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)
Duties which may only be performed by a pharmacist: **
- 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
Pharmacy Technician and Trainee Duties
- 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
Differences between Technicians and Trainees in Class A Pharmacy
None
Environment Standards
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
Security Requirements
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
Temporary Absence of A Pharmacist - On-site
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
Temporary Absence of a Pharmacist - Off Site
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
Patient Counseling Requirements
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.”
Refusal of Counseling
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.
Drug Regimen Reviews - At minimum , the pharmacist must review and identify what for a new drug?
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)
15 Labeling Requirements for Dispensed Drugs
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