L2 - Class A: Community Pharmacy Rules (pt1&2)

How many Pharmacist-In-Charge (PIC) are usually in one pharmacy and what are their responsibilities?

Generally one PIC per pharmacy, with exceptions. They have many responsibilities including legally operating the pharmacy

T/F: The owner of the pharmacy also has responsibilities

True

What are some general rules a pharmacist must follow when working?

- physically present supervise technicians

- electronic supervision of technicians

- electronic verification of data entry by technicians

- dispensing pharmacist's responsibility

- duties only pharmacist can perform

What are the duties of a pharmacy technician?

- can't perform required acts of pharmacists

- review list of duties from rule book

- can now take verbal prescriptions for dangerous drugs (not controlled substances) and perform transfers

What is the ration of pharmacist to technicians in a community pharmacy?

1:6

- not more than 3 may be pharmacy technical trainees

What are the licensing requirements of a pharmacist?

- register with the board

- 1 license per location

- notify the board of ownership

- compounding (specific licensing)

What does the Board have to be notified of regarding ownership of a pharmacy?

- Changes in ownership or managing officer changes w/in 10 days

- within 10 days of closing in writing

What are the licensing requirements of a Compounding specific pharmacy?

- non sterile rules

- sterile must register as Class A-S

What are the requirements of a pharmacies environment?

- serving general public, must have area suitable for patient counseling

- sink external of restrooms

- no animals does not include fish and service animals

What are the requirements of security within a pharmacy?

- prescription department must be locked

- PIC may authorize persons to enter prescription department

- pharmacies must have security policies and procedures implemented by PIC

* controlled substances

* opening and closing procedures

- patient may pick up Rx already filled; treat as a "delivered" prescription

What happens when a Pharmacist is Off-Site?

- the pharmacy is essentially closed

- technicians cannot remain in the prescription department

When a Pharmacist is Off-Site, what happens to filled prescriptions?

authorization may be granted to an agent of pharmacist to deliver already filled Rxs for a short period of time not greater than two consecutive hours per day (treated like a "delivered" Rx)

When a Pharmacist is Off-Site, a notice must be posted with what information?

- that the pharmacist is off-site and not present in the pharmacy

- no new prescriptions may be prepared, but previously verified prescriptions may be delivered

- date and time when pharmacist will return

When a Pharmacist is Off-Site what should happen when prescriptions are picked up?

detailed information about the patient and patient/agent picking up should be recorded

Why is there Mandatory Counseling (no offer) for New Prescriptions?

to optimize drug therapy, a pharmacist shall communicate to the patient or agent information they deem significant

What is considered a 'New' Prescription, that a pharmacist would have to give mandatory counseling?

same dosage and strength not dispensed to patient by the pharmacy within past 12 months

What forms of counseling are required for a 'New' Prescription?

both verbal and written

- there are exceptions

Who in the pharmacy can provide patient counseling?

only a pharmacist (intern with preceptor) may verbally provide information to a patient or agent and answer questions

- non pharmacists including the pharmacy's computer system may not ask questions of patient or agent intended to screen/limit interaction with pharmacist

How must patient counseling be documented?

Initials or ID code of pharmacist providing counseling on prescription hard copy, if the data processing system, in an electronic logbook, or hard-copy log

What must be done if a prescription is delivered either in the pharmacy when pharmacist is temporarily absent or delivered to a patient's home?

written information is required and notice that pharmacist is available via toll-free telephone number

What are the requirements for a Generic substitution?

labeling requirements

- may dispense a generically equivalent

For a Dosage Form Substitution to occur what is required?

- patient consents the substitution

The dosage form dispensed:

- contains the identical amount of the active ingredients

- is not an enteric coated or time released product

- dose not alter desired clinical outcomes

In order for a Therapeutic Interchange what must occur?

approval of prescriber

- switching prescription to a different drug cannot be done without approval

What are the Exceptions when a pharmacist would not need to get approval from a prescriber before switching prescriptions to a different drug?

Facilities where drugs are administered to patient by a person required by law and issuing practitioner has agreed to formulary list of therapeutic interchange

Who needs be notified when a Therapeutic Interchange will occur?

Patient

- pharmacist/pharmacy must maintain documentation of all communication with prescribers

A Pharmacy must provide notification on safe disposal when dispensing a ____ controlled substance

Schedule II

When would a pharmacy not be required to provide a notification?

- if the pharmacy is an "authorized collector"

- or provides mail in pouches to patients for disposal

What are the labeling requirements for an Rx from APRN/PA?

you do not need the name of both the physician and APRN/PA on the label

- only the APRN/PA

What are the labeling requirements for an Rx from a pharmacist?

you need both names on the label

What is the Beyond-use date required for prescription containers & labeling?

is one year from date dispensed -or- manufacturer's date if less than one year

In what situations can alternative labeling be used?

for nursing homes, hospices, and hospitals "inpatients"

Under what circumstances can undelivered medication be returned to stock?

- Rx have not been picked up or delivered

- Pharmacist must evaluate circumstances

- cannot be mixed with manufacturers stock bottle

- must be dispensed in a new Rx container with certain exceptions

T/F: Libraries can be hard copy or electronic access

True

T/F: Prepackaging of drugs only for internal distribution

True

What are customized patient compliance packaging?

allows to or more drugs to be placed in same container. Ex. amazon pillpack

What are the special labeling requirements of customized patient medication packages?

must contain date of preparation and beyond-use date (not more than one year)

What are the 3 types of automated systems in pharmacy?

- compounding and counting devices (Baker Cells)

- automated dispensing systems

- automated checking devices

Records must be available for how long?

at least 2 years and must be provided within 72 hours of request

Which records must be maintained separately?

C-II

Which records must be maintained separately from dangerous drug records?

C-III through V

- or be readily retrievable

What type of records shall be maintained in a data processing or direct imaging system?

records with certain exceptions and provisions

Records of prescriptions must be available for how long?

for at least 2 years and must be provided within 72 hours of request

look at slide 24 "Prescriptions", is the same as the records info

24 :)

What prescriptions can be Electronic (not fax)?

- dangerous drugs

- controlled substances

* must meet strict DEA requirements

* mandatory unless an exception applies

What prescriptions can be Fax?

- dangerous drugs

- schedule III-V

- schedule II: only in specific situations

Under what circumstances can Schedule III-V be Faxed?

treated as verbal so only valid in emergency

Original prescription drug order records are in what file system?

_____ (TBSP requirement)

slide 27

What is the general rule of PRN Refills?

not valid more than one year

What are the emergency refill rules?

- 72 hours

- 30 day

- special rule for insulin

Auto Refills are not allowed for what schedule controlled substances?

Schedule III

Accelerated Refills are allowed under what circumstances?

- patient must be 18

- not for psychotropic drugs

When should Records be in a Manual System?

if you don't keep records electronically

- must manually document all changes to Rx

How many times should records in computer systems be backed up?

at least monthly

What should be kept in the records in computer system?

must record specific information including identification of person performing data entry

When should a computer system record be able to produce a copy?

must be able to produce a hard copy within 72 hours

What must a pharmacist do when keeping records in a computer system?

must sign a daily log that information entered into computer is correct

- log must be signed within 7 days

When are transfers of prescriptions allowed?

one time only for Schedule III-V

- unless pharmacies share a common database

Transfer of Prescriptions can only be done by?

must be pharmacist to pharmacist, pharmacist to intern, or intern to intern

- tech duty rules?

When is a transfer of an original (not yet filled) prescription allowed?

for dangerous drugs

When is a transfer of an original (not yet filled) prescription NOT allowed?

for controlled substances unless Rx is electronic

Transfers of prescriptions must be completed within what amount of time?

4 hours of a request

T/F: cannot refuse to transfer a prescription

true

T/F: Transfer of prescriptions can be bulk or multiple

true

Class A pharmacies that perform sterile compounding must be licensed as what type of pharmacy?

Class A-S

Why do Class A-S pharmacies need to be specially licensed?

allows the Board to identify which pharmacies are performing sterile compounding

Class A pharmacies licensed as a Class A-S pharmacy as still subject to what rules?

still subject to all Class A rules and all compounding rules