EXAM 3 Rules of the Board Pt3

Question 1

When shall a pharmacist counsel and when shall they offer to counsel?

Answer 1

-new Rx: Shall counsel

-Refill: Shall offer to counsel

the patient can refuse: must be refused FACE-to-FACE (often on a tablet)

Question 2

8 counseling topics

Answer 2

check OBRA 90 or 1400-01

Question 3

In which facility are pharmacists required to counsel?

Answer 3

-outpatients when meds are dispensed at discharge (patient leaving the hospital)

-not inpatient (when they are still in the hospital)

Question 4

Pharmaceutical care

Answer 4

-maintain medical record of patients
-keep basic infos (name, address etc) and individual history
-see OBRA 90

Question 5

What must be on an Rx order?

Answer 5

-Written order must be signed by the prescriber
-Verbal orders must immediately be reduced to writing, dated and initialed by the person receiving the order

-Serially numbered
-Maintained for 2 years from last dispensing (may be the date of refill)

-pharmacist must initial, date, and record the amount that was dispensed

-refills also need initials, date, and indicate the amount on the back of the original

Question 6

Computer systems have to have …

Answer 6

-On-line retrieval of original and complete refill history, including the dispensing pharmacist

-All Pharmacists dispensing must certify accuracy each day (maintained for 2 years)

-Must be able to produce hard copy print out of any/all order(s) with controlled substances identifiable in some way

-Must have a “backup” plan for downtime

Question 7

An authorized refill always needs a hard copy of the Rx.
T/F

Answer 7

False.

can authorize a refill based on the patient’s profile information
-the profile has to have all the information required for an original Rx (includes refill history)
-controlled substances identifiable in some way
-has a complete history of all others
-maintained for 2 years

-the Pharmacist has to certify (autograph) that the profile is accurate and valid

Question 8

Dispensing in strict conformity

Answer 8

Rx orders should be compounded and dispensed in strict conformity (compound and dispense as it is prescribed)

-if they have a PRN for a 30-day prescription -> refill only after 30 days

dispense at a rate that is safe for public health and welfare (next second slide)

Question 9

How long is a prescription valid in TN according to the board?

Answer 9

max 1 year

-doesn’t say if controlled or non-controlled

Question 10

What must the recipient of a transfer Rx record?
***

Answer 10

-name, address, and original serial number from the original pharmacy
-name of the transferor
-all information constituting an order (all info that you need to have on an original Rx)
-DEA number if it is a controlled substance

-transferee (receiver pharmacist) informs the patients that the original Rx has been canceled from the pharmacy from which it was obrained

Question 11

Unused Meds

Answer 11

pharmacist, techs, and interns are allowed to receive the return of any portion of an order that has been taken at the pharmacy

-how to discard the meds depends on if it is a controlled substance (have witness or send back)

Question 12

solicit

Question 13

Can a fax order be used as the original Rx?

Answer 13

Yes, only at the option of the patient (?)

-the fax has to be of good quality (should not fade after time)
-it has to be filled at the pharmacy at where it stated it was sent (so if it says: Fax to pharmacy AB -> the pharmacy AB cant send it to another pharmacy to be filled, has to be filled at the pharmacy that received the fax - so pharmacy AB)

Question 14

What are the requirements for electronic orders?
Can an E-Rx date be used as the original?

Answer 14

-only from a prescriber (or agent, nurse) to the pharmacist or an area in a pharmacy under direct supervision of the pharmacist

-has to include:
Prescriber phone (to verify the Rx)
Date and time
Pharmacy name
electronic signature (+ agent signature if they send it)

-the electronic data is considered the original

Question 15

What should be on a Rx label in TN?
OUTPATIENT

Answer 15

-Name, address, phone of pharmacy
-Serial number
-Prescriber name
-Patient name
-Directions
-Original date and refill date

-Name of product
-Expiration date
-Advisory label

-make accommodations for visually impaired patients
-rules don’t apply to institutional/LTC pharmacies
-applies to assisted-living facilities (since the patient is in possession of the drug)

Question 16

How long can a pharmacist be absent from the pharmacy?

Answer 16

Should not exceed 1 hour per day (don’t need to use 1 hour break, not a requirement)

when absent:
need a sign saying: Pharmacist not on duty
nothing can be dispensed or compounded
Rx department must be closed (physical barrier)

Question 17

What must be done when Repackaging meds?

Answer 17

-must be supervised by a pharmacist (with in-process and end-process verification

-> need a mechanism that verifies that all that goes into a different package matches all of the information that you had on the original package, no adulteration or misbranding)

Question 18

Repackaging inpatient setting

Answer 18

when packaging into a unit dose container need:

-Name, strength, drug quantity
-Manufactures Name, Lot or control number
-expiration date
-advisory label

-may assign a batch number that contains all the info when scanned (bv ot enough space on the container)

Question 19

When should a loss of Rx drugs be reported to the board?

Answer 19

Immediately by the PIC

-robbery, embezzlement, theft, burglary, fire, disaster
-provide a list of all lost drugs including controlled substances

Question 20

When do outdated/deteriorated drugs have to be returned or destroyed?

Answer 20

immediately by the PIC

-controlled substances shall be performed by an approved vendor (reverse distributor)

Question 21

How should legend drugs and syringes be stored?

Answer 21

-legend drugs stored not accessible to the public

Syringes
-syringes and insulin not accessible to the public
-syringes must be sold with proof of medical need
-sold under the supervision of a pharmacist
-counseling not required

-generally, pharmacy deliveries are permitted

Question 22

How are meds loaded into automated dispensers in an ambulatory pharmacy/community pharmacy?

Answer 22

-lot number of each drug needs to be posted
-cleaned after each lot
-cant mix lots (can’t put 2 different lots of meds in one cells)
-loaded by pharmacist or tech/intern under the supervision of the RPh

Question 23

What are the requirements for pharmacists in charge?

Answer 23

-the board has a record of all PIC
-can only be PIC of one pharmacy
notify the board if the PIC resigns or dies
-the PIC must conduct an inventory of controlled substances with the successor PIC (new PIC)
-inventory should be kept for 2 years
-PIC maintains a list of techs (but not pharmacists)
-the PIC must be on duty 50% of hours open, but must not be there more than 40 hr
-must report serious injury/death from a med/Rx order
-> Highlights of the list

Question 24

Which Book must be maintained by the pharmacist?

Answer 24

-adequate reference library that is consistent with the scope of practice (can be printed or electronic)

-the current edition of TN Pharmacy Laws

Question 25

Central Pharmacy processing of Rx

Answer 25

-both pharmacists must be licensed in TN

-must share a common electronic file or be able to access pt info

-Can be the same owner (CVS) or have a contract in place

-Central pharmacy must have policies and procedures manual (need to be presented to an investigator of the board if needed)

Answer 26

-know the 9 definitions

-the executed agreement and written attestation must be filed to both boards (medical and pharmacy board)

-the patient must know about and consent to it

-can have CPA with mid-levels (PA or APN) -> physician with responsibility must approve/sign (3 boards have to know about it)

-minimum of 1 mill in liability coverage

Question 27

Who is eligible to have a CPA?

Answer 27

-Pharm D holders
-BS pharmacists in active practice
->2000 hr of work in the last 24 months

Question 28

What must be in the CPA

Answer 28

-Name and titles of collaborating providers (or the hospital/clinic)

-care and the service provided:
nature and scope (ex: prescribe HTN or diabetes meds)
immunizations, naloxone, ivermectin, and preventive care are exempted

-documentation and communication
document what has been done with the patient and it must be accessible to the physician or you may send it to him within 3 days
maintain these healthcare records for 10y

Question 29

When does not fall into the scope of practice in a CPA?

Answer 29

Non-patient specific care:
except for immunizations, naloxone, ivermectin

Prescribing of controlled substances
except for institution or hospital-based care

Question 30

How many hours of CE are required for pharmacists in CPA?

Answer 30

-encouraged (not required) to complete 10 hr of CE in “topics related to the clinical practice of pharmacy”
every biennium (every 2 years)

-must complete 2 CEs related to controlled substance prescribing if they have a DEA number and prescribe controlled substances (in an institution or hospital)

Question 31

A pharmacist prescribes Ivermectin under a CPA, what does he have to provide?

Answer 31

Ivermectin is one of the exceptions of Non-patient specific CPAs

-must follow standardized procedures

-screening assessment looking at:
comorbidities
contraindications
pregnancy

-provide a standardized fact sheet of Ivermectin