Class A Rules Study Guide Flashcards by Beth Cocker

Can a pharmacist serve as PIC for more than one pharmacy?

Yes

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What are the limitations on a pharmacist being a PIC at more than one store?

Pharmacies can’t be open simultaneously, if it’s an emergency situation they have to spend 10+ hours/week in each pharmacy (this can’t continue for more than 30 days)

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What are the responsibilities of the PIC?

Basically same as all other pharmacist duties

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What are the specifications for using electronic means to supervise prescription data entry?

Pharmacist on site & has immediate access to any original document containing prescription information or other information related to the dispensing of the prescription (access via imaging technology as long as have access to hardcopy if needed)

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What duties may technicians lawfully perform?

Only nonjudgmental duties associated with preparation and distribution of prescription drugs
AKA: Initiate/receive refill authorizations, data entry, assembly, reconstituting, filling automated machine, compounding

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Describe the process of training pharmacy technicians

???

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When can pharmacy technician training be transferred to another pharmacy?

Common ownership b/w pharmacies & have common training program, PIC in each pharmacy certifies the tech is competent to perform assigned duties

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Who is responsible for monitoring technician training and maintaining a training manual?

PIC

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**Report in writing to TSBP w/in 10 days

Change ownership, location/name, managing officers; closing a pharmacy, change PIC, theft/significant loss of any controlled substances, disaster/accident/emergency affecting drugs or devices immediately, sale/transfer of controlled substances or dangerous drugs on the permanent closing or change of ownership, loss of information from computer system, pharmacist & intern change of address
Copy of any notification must be kept by reporting pharmacy for 2 years & be available for inspection

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Counseling area must be:

Confidential
Easy access
Private

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Sink and compound area must:

Sink: hot and cold water withing pharmacy (exclusive of restroom facilities, soap/detergent and air drier/single use towels must be provided

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Animals, flammables, temperature for drug storage:

No animals in the pharmacy

Flammables have to have designated storage area

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Security Requirements

o Each pharmacist on duty is responsible for security of prescription department, including provisions for effective control against theft or diversion of prescription drugs & records
o If prescription department is closed at any time the rest of the store is open – pharmacy must be physically or electronically secured
 Floor to ceiling walls; walls/partitions/barriers at least 9’6” high; Motion detectors
 Basic alarm system at a minimum
o PIC or owner may designate persons to enter prescription department to perform functions (other than dispensing/prescription processing), must maintain written documentation of authorized individuals

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What are requirements for library in a Class A pharmacy?

 Current copy of laws/rules (Texas CSA, Texas DDA, Texas Pharmacy Act, Federal CSA)
 At least 1 current or updated reference from each of the following
• Patient information (USPDI vol II), drug interactions (Hansten’s Drug Interactions), General information, basic antidote information & phone number of nearest regional poison control center

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What are limitations of pharmacy break periods?

If only 1 pharmacist on duty, pharmacist may leave for short period if: 1 tech stays, pharmacist stays on site & immediately available, pharmacist reasonably believes that security of department will be maintained

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What tasks may technicians & other supportive personnel complete while pharmacist is on break?

Everything except give prescription to patient

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What is the maximum time a pharmacist may be absent from the pharmacy in a 24 hour period?

Cannot exceed 2 consecutive hours

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What information must the pharmacist provide when counseling a patient regarding a prescription medication?

Any of the following based on professional judgment: Name of drug, dosage form/route, duration, special directions, side effects, self-monitoring, storage, refill information, what to do if miss dose

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When is a pharmacist required to counsel a patient regarding a medication?

All new prescriptions and any time patient requests counseling

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When is a pharmacist required to provide written information to a patient regarding a prescription medication? What must this written information contain?

Written information given with all prescriptions (major active ingredients); easy language, “do not flush”, information on all active ingredients of compounded product

When a prescription medication is delivered to a patient’s home, what information must be provided to accommodate for patient consultation?

Written information, toll free number to a line answered in normal hours so they can talk to pharmacist

When is Drug Regimen Review required?

Prior to or at time of dispensing of a prescription

Can Drug Regimen Review be conducted off-site? If so, what are the requirements for off-site DRR?

Yes – pharmacist must be a Texas licensed pharmacist employee of pharmacy, pharmacy takes measures to protect patient privacy; pharmacist can be an employee of Class E pharmacy as long as written contract that outlines services to be provided

Room temperature

15-30°C or 59-86°F

Cool Temperature

8-15°C or 46-59°F

Refrigerated Temperature

2-8°C or 36-46°F

Frozen Temperature

-20 to -10°C or -4-14°F

Label Requirements

Brand name & strength (or generic name, strength & manufacturer/distributor), facility’s lot number, expiration date, quantity of drug if >1

Record Requirements

Name of drug, strength, dosage form; facility’s lot number, manufacturer/distributor, manufacturer’s lot number, expiration date, quantity per prepackaged unit, number of units, date packaged; name, initials or electronic signature of packer; signature or electronic signature of pharmacist

How often must a machine that counts and dispenses solid dosage forms be tested?

At least every 6 months (minimum 2 times/year)

How often must a machine that serves as an automated prescription checking device be tested?

At least monthly

Who may lawfully fill the canisters of an automated dispensing system?

Pharmacist or technician (pharmacist must check off on it)

Describe the device with proximity to pharmacy and building

* Within the pharmacy building so pharmacy staff has access to it from within the prescription department * Patients have access from outside prescription department * Can’t be located on outside wall, may not be access from a drive through window

This device must make a digital image of each person receiving prescription medications from the device and retain these images for how long?

Record kept for 2 years

What types of drugs may be dispensed through one of these machines?

Refills only; no new prescriptions (b/c need counseling), no controls, no refrigerated items (depending on system used)

What provisions are made for patient consultation should a patient request to speak with a pharmacist?

Telephone that connects to another pharmacy or phone number of pharmacy available

Accelerated refills

For Dangerous Drugs only (legend drug = dangerous drug…not controls) Limit: may dispense up to 90 day supply if quantity prescribed allows Psychotropic drugs used to treat mental illness are prohibited from accelerated refill Patient must be 18 or older

Prescriptive authority for ANP and PA for controlled substances

o is for a Schedule III, IV or V substance (no CII’s) o is for a period not to exceed 90 days o may be refilled only after consultation with the delegating physician and the consultation is noted in the patient’s chart o if for a child under 2, the prescription is issued after consultation with the delegating physician and the consultation is noted in the patient’s chart o the APN or PA is practicing in accordance with the Texas Medical Practice Act, Section 3.06(d)

Transfer of Prescription between two pharmacies: Interns

only one person transferring the prescription may be an intern; a prescription shall not be transferred between two interns

Transfer of Prescription between two pharmacies: Prescriptions for Schedule III, IV, V

may be transferred ONCE

Transfer of Prescription between two pharmacies: Refusual

An individual may not refuse to transfer a prescription to another individual who is acting on behalf of a patient

Transfer of Prescription between two pharmacies: Online real time data system

The pharmacist in the transferring pharmacy shall review the message and document the review by signing and dating a hard copy of the message or a log book containing the information

How long from the time of transfer must the document be signed and dated?

72 hours

Auto Refill Program

Patients must be notified of program and offered the option of enrolling; patients can discontinue service at will

The daily, hard-copy printouts of pharmacy daily business must be printed out _____ (how often).

72 hours

The pharmacist must review and sign the daily, hard-copy printout (or the associated signature log book) within _____ (how long) of the date of dispensing.

7 days

The computer system must be able to produce an audit trail for ____ (time period).

2 years

The computer system must record the identity of each technician and pharmacist that works on a prescription. This includes: data entry, information verification and patient consultation. This information must be retained for _____ (time period).

2 years

*****All pharmacists in addition to the PIC should be able to locate the following records when on duty for the previous 2 years.

 Annual inventories  Executed DEA 222 forms  Controlled substances invoices  Theft and loss reports  Drug destruction reports  All prescriptions  DEA and DPS registration certificates if they are not posted  Daily dispensing printouts or dispensing logs  Prepackaging records if applicable  Technician training manual and documentation of technician training.