Section 6: Class A (Community) Pharmacy Rules TX

Each Class A pharmacy shall have ____ PIC who is employed ____.

One; full-time

Can a PIC serve as PIC for 2 Class A pharmacies?

No, generally they can be PIC of only one Class A pharmacy unless the other Class A is not open at the same time

When can a PIC serve as PIC for 2 Class A pharmacies open at the same time?

During an emergency, but only if they work at least 10 hours per week in each pharmacy for no more than 30 days

What are the responsibilities of PIC?

-Legal operation of pharmacy

-Educating/training pharm techs

What are the responsibilities of the owner?

All administrative and operational functions of the pharmacy

If the owner is not a pharmacist, what must they do to establish polices and procedures?

Consult with the PIC or another pharmacist

What are the responsibilities of the pharmacists?

-Supervise pharm techs and trainees

Can supervision of pharm techs and trainees be done electronically?

Yes, if the pharmacist is on-site in the pharmacy and other conditions are met

What is the definition of a dispensing pharmacist?

The pharmacist who performs the final check

What is the dispensing pharmacist responsible for?

Ensuring that drugs are dispensed safely and accurately as prescribed unless the pharmacy's computer system can ID each pharmacist involved in different steps of the dispensing process such as drug regimen review, verification of data entry, labeling, etc

Who can receive oral prescription drug orders and put them in writing?

Pharmacist

Who can interpret prescription drug orders?

Pharmacist

Who can select drug products (as in generic drug product selection)?

Pharmacist

Who can perform the final check of a dispensed prescription?

Pharmacist

Who can provide patient counseling?

Pharmacist

Who can assure that a resonable effort is made to obtain, record, and maintain patient medication records?

Pharmacist

Who can interpret patient medication records and perform drug regimen reviews?

Pharmacist

Who can perform drug therapy management under protocol?

Pharmacist

Who can verify that the controlled substances listed on invoices are received by initialing and dating invoices?

Pharmacist

Who can transfer or receive a transfer of a prescription?

Pharmacist

What are the responsibilities of pharmacy technicians and trainees?

To provide nonjudgmental, technical services associated with the dispensing of a prescription drug order

Who can initiate and receive refill authorization requests?

Pharm techs and trainees

Who can initiate electronic transfer requests between pharmacies sharing a common database?

Pharm techs and trainees

Who can enter prescription data into a computer system?

Pharm techs and trainees

Who can take a stock bottle from the shelf for a prescription?

Pharm techs and trainees

Who can prepare and package prescription drug orders?

Pharm techs and trainees

Who can affix prescription labels and auxiliary labels on a prescription?

Pharm techs and trainees

Who can reconstitute medications?

Pharm techs and trainees

Who can load bulk drugs into an automated counting or dispensing device?

-Pharm techs and trainees

-However, a pharmacist must verify prior to use

Who can participate in bulk compounding?

-Pharm techs and trainees

Who can compound non-sterile prescription drug orders?

-Pharm techs and trainees after appropriate training

Who can compound sterile preparations in a Class A-S pharmacy?

-Pharm techs and trainees after appropriate training

who can receive oral prescription drug orders for dangerous drugs and reduce them to writing either manually or electronically?

Pharmacists

Pharm techs/trainees

who can transfer or receive a transfer of original prescription information for a dangerous drug on behalf of a patient?

Pharmacists

Pharm techs/trainees

Who can contact a prescriber for information regarding an existing prescription?

Pharmacists

Pharm techs/trainees

is there a difference between the duties of a pharm tech and pharm tech trainee

NO, there are no differences

What is the ratio of on-site pharmacists to technicians/trainees in a Class A pharmacy?

1:6

as long as the max # of pharm tech trainees is 3

what are the environment operation standards of a class a pharmacy

- orderly/clean

- sink with hot/cold running water, exclusive of restrooms

- if serving the public, a pt counseling area designed for maintaining confidentiality

- appropriate lighting and temp

- no animals allowed

- designated area for flammable materials

what are the security operation standards of a class A pharmacy that possesses drugs

- prescription department must be locked to prohibit unauthorized access

- key or mechanism of locking cannot be duplicated

- Minimum must have basic alarm system with offsite monitoring and motion detectors

- must have written protocols and security

Can the PIC or owner authorize individuals to enter the prescription department to perform functions other than dispensing?

YES BUT they must maintain WRITTEN documentation of authorized individuals other than those employed by the pharmacy that accessed the prescription department when a pharmacist is not on site

if there is only one pharmacist onsite and needs temporary absence for meals and breaks, what must occur?

- at least one pharm tech remains in pharmacy

- pharmacist must remain on pharmacy premises

- notice must be posted that pharmacist is on break

what can a pharm tech do when the pharmacist is on temporary absence for meals/breaks? what does the pharmacist when they come back from break?

pharm tech can process prescription drug orders or refills, but they CANNOT be delivered until pharmacist returns and verifies accuracy of prescription

Pharmacist must conduct drug regimen review and verify all activities performed by tech

what does the pharm intern act as when the pharmacist is on temporary absence for meals/breaks?

as a pharm tech

how can a pt pick up a new prescription where counseling is required when the pharmacist is on temporary absence for meals/breaks?

the rules allows you to treat the prescription the same way you would treat a new prescription that is delivered to the patient in their home.

counseling is provided by giving written information about the drug and a notice that the pt can call the pharmacist if the pt has any questions

Can the pharmacy department stay open if the pharmacist leaves the premises? can the pharm techs stay if pharmacist is not on premises

no, pharmacy department has to close

no pharm techs must also leave premises

Under what conditions can filled prescriptions be delivered to a pt during the short period of time pharmacist is NOT on premises? does the delivery need to be recorded

agent of pharmacist can deliver previously verified prescription can be delivered to a pt given the period of time does NOT EXCEED 2 consecutive hours in a 24 hour period

yes, the pharmacy must keep record of date of delivery, prescription number, and signature of person picking up the prescription

what kinds of prescriptions have mandatory patient counseling?

new prescription drug orders

including prescriptions not dispensed to pt by pharmacy in the same strength AND dosage form within the past 1 year

what must be provided to a patient during pt counseling for a new prescription? does pt counsling need to be documented by the pharmacist?

verbal/written info (written info can be electronic including email)

type of written info given needs to be documented

yes, pharmacist must document initials or identification code of pharmacist on prescription or in computer system

can a pharmacist not give pt counseling for a pt refusing counseling on a new prescription drug order?

NOOO

pt counseling is required for ALL NEW PRESCRIPTION ORDERS

any refusal of counseling by a pt or pt's agent MUST BE DOCUMENTED

A drug regimen review is required for ______ prescriptions

what shall be reviewed/identified as clinically significant at a minimum?

ALL

1. known allergies

2. rational therapy-contraindications

3. reasonable dose/route of administration

4. reasonable directions of use

5. duplication of therapy

6. drug-food interactions

7. drug-drug interactions

8. drug-disease interactions

9. ADRs

10. Proper utilization including over utilization and underutilization

labeling requirements for dispensed prescriptions (11)

1. name, address, and phone # of the pharmacy

2. prescription # (no smaller than 10 pt font)

3. date dispensed

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

5. name of prescriber

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

7. name of pt (if animal - species of animal/owner of animal)

8. instructions for use (no smaller than 10 pt font

9. appropriate ancillary instrucitons

10. name/strength of drug dispensed unless otherwise directed by prescriber

11. a beyond-use-date that is not greater than one year from the date dispensed or the manufacturer's expiration date whichever is shorter

what must be included on the label of dispensed prescriptions if generic substitution has occurred

"substituted for Brand Prescribed" or

"substituted for Brand name"

what must be included on the label of dispensed prescriptions if drug is a C2-4

"Caution: Federal law prohibits the transfer of this drug to any person other than the pt for whom it was prescribed"

when are the labeling requirements not required to be met?

if the drug is for administration to an ultimate user who is institutionalized (hospital or nursing home pt)

AND no more than a 90 day supply is dispensed at one time

who should be provided the notification of safe disposal of C2 CS? which pharmacies are exempt from providing this notification of safe disposal?

the patient (must include info on locations where C2s are accepted for safe disposal) that went a class A pharmacy that dispenses a C2 prescription

exceptions:

a pharmacy that is registered w/the DEA as an "authorized collector" of CS and regularly accept CS for safe disposal

a pharmacy that provides to the pt at the time of dispensing and at no cost either a mail-in pouch for surrendering unused CS

Can prescription that have not been picked up or delivered be returned to stock for dispensing?

YeS

BUT they cannot be mixed in with manufacturer's containers and must be placed in new containers

what hard copy or electronic resources must be in the pharmacy's library?

1. Laws and rules - TX pharmacy act and rules; Texas Dangerous Drug Act and rules, Texas Controlled substances Act, and Federal Controlled Substances Act

2. At least one current vernal drug info reference that includes drug interaction info

3. if the pharmacy dispenses veterinary prescriptions, a general reference on veterinary drugs

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

how often does an automated pharmacy dispensing system need to have its accuracy tested

every 12 months

or

when an upgrade or change is made to system

how can a final check of an automated pharmacy dispensing system be accomplished by?

A pharmacist checking the final product after the automated system has completed the prescription and prior to delivery to pt

OR

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

All records in a Class A pharmacy should be maintained for how long?

2 years

schedule II records shall be maintained ________ other records

separately from

Schedule III-V records, other than prescriptions, shall be maintained __________ other records

separately or "readily retrievable" from other records

what does readily retrievable mean?

CS records are asterisked, redlined, or in some other manner readily identifiable from other items in the record

how long shall the hard copy originals of C II-V be kept?

DEA requires they be kept for 2 years

Patient medication records are required for _______ ______ patients.

What must the pharmacy provide?

all new patients

pharmacy must provide for the immediate retrieval of information for the previous 12 months to conduct a drug regimen review

what information must the PIC assure that reasonable effort is made to obtain and record in a patient medication record?

1. name, address, and phone # of the pt

2. age/gender of pt

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

4. other drugs currently being used by the pt

5. Pharmacist's comments relevant to drug therapy

6. A list of all prescription drug orders dispensed (new/refills) to the pt by the pharmacy during the last 2 yrs

For management of records in a Class A pharmacy, the computer system needs to be backed up how often?

at least monthly

For management of records in a Class A pharmacy, the computer system must maintain any information (records) purged from computer for how long from the date of final entry of data?

2 years

For management of records in a Class A pharmacy, the computer system needs to have the capacity to produce a daily hardcopy printout consisting of what?

- prescription number

- date of dispensing

- pt 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 the pharm tech performing data entry

- any changes made to a record of dispensing

For management of records in a Class A pharmacy, the computer system needs produce daily hardcopy within how much time of the date the prescriptions were dispensed?

72 hours

what log must be maintained in the pharmacy for at least 7 years from the date of transactions?

Log of unique initials or identification codes of each pharmacist, pharm tech, or trainee who was involved in the dispensing process

Can pharm techs perform transfers of CS prescriptions?

No pharm techs cannot perform transfers of CS prescriptions?

Transfers of CS prescriptions are allowed once UNLESS...

the pharmacies share an electronic, real-time database

is the electronic transfer of multiple or bulk prescriptions allowed?

yes it is allowed