RX PREP Chapter 3: Pharmacy Operations

Question 1

foreign trained pharmacists must complete the ____ by passing the FPGEE and the TOEFL

Answer 1

FPGEC; once complete, also have to complete the state’s required internship hours

Question 2

what type of pharmacist has prescriptive authroity?

Answer 2

clinical pharmacist practitioner or advanced practice pharmacist

Question 3

What are the two primary certification exams for the pharmacy technician certification board?

Answer 3

pharmacy technician certification examination

exCPT pharmacy technician certification exam

Question 4

description: license is restricted for a specified period of time

Answer 4

action: probation

Question 5

description: license is inactivated; it may be reinstated after conditions are met

Answer 5

suspension

Question 6

description: license is taken away by the licensing agency

Answer 6

revocation

Question 7

individual agrees to voluntarily give up license often under pressure to avoid penalties and or criminal charges

Answer 7

surrender

Question 8

license that lapsed, was suspended or revoked is returned to active status authoring practice as defined by that license

Answer 8

reinstatment

Question 9

what are the most common causes of disciplinary action?

Answer 9

impairment, drug theft, and drug diversion

Question 10

who has the final authority over disciplinary proceedings?

Answer 10

the board

law enforcement can be involved

Question 11

when applying to open a pharmacy, what is often required as part of the licensing application?

Answer 11

• the physical address
• classification (community, hospital, speciality)
• name and license # of PIC
• fee
• NPI # for pharmacy

Question 12

after initial approval of the pharmacy, the DEA will send a registration renewal notice to the registrant ___ days prior to the expiration

Answer 12

60 days

Question 13

for out of state and mail order pharmacies, should the pharmacy or pharmcist be licensed?

Answer 13

both - almost all states require out of state and mail order pharmacies to be registered or licensed in the state where the PATIENT LIVES

*the PIC may or may not

Question 14

for pharmacy inspection, the items inspected commonly include

Answer 14

record keeping systems

compliance with the controlled substance act

temperature logs for fridge

Question 15

the pharmacy space must be secured by

Answer 15

a physical and or electronic barrier

Question 16

in the event that the prescription information is permanently lost due to a power outage, the board of pharmacy should be notified within __ hours

Answer 16

24h

Question 17

tha NABP, in the model act, recommends that all information recorded manually during a lapse in the computer system be entered within __ hours from the time the system is back up and operable

Answer 17

96h

Question 18

What are the records that MUST be kept by pharmacies?

Answer 18

-patient profile for every person who has filled a rx
(patient name, address, phone, dob, gender, drugs)

• dispensing record for each rx
  (prescription #, name and manufacturer, quantity with each fill, name or initials of dispensing pharmacist, date of fill/refill, number of refills remaining

-receipt for all drugs purchased and received by the pharmacy
(transaction information, transaction history, and a transaction statement to satisfy drug supply chain security act)

compounding log

DEA Form 222, inventory

logbook for the OTC sale of ephedrine/pseudoephedrine products

*2 years-federal

Question 19

an _____ facility provides a physical location for patients to receive extended healthcare services

Answer 19

institutional (hospitals, assisted living facilities, LTCF, nursing homes, rehab center, drug abuse treatment centers)

Question 20

an ____ pharmacy provides pharmacy services to any institutional facility and may or may not be physically attached to the facility

Answer 20

institutional

Question 21

when a pharmacy is not physically attached to the institution, a licensed _____ can be authorized to restock automated dispensing systems with verification technology, such as barcode scanning

Answer 21

nurse

Question 22

a valid prescription drug order in an institutional facility is called a _____ or _______

Answer 22

chart order or medication order

• these drugs are entered DIRECTLY into the chart or medical record
  the order is ongoing until the dr discontinues unless an automatic stop date is specified

Question 23

T/F

chart orders are exempt from the standard prescription requirement

Answer 23

true

Question 24

what must a chart order include?

Answer 24

patient name

date of issue

drug name, strength, dosage form

directions of use

prescriber signature

Question 25

T/F a pharmacy within an institutional facility may be without a pharmacist for designated periods of time

Answer 25

true - the pic must have procedures in place for authorized individuals to obtain medications and there must be a pharmacist on call during absence

Question 26

a supply of drugs should be available inside the pharmacy in a locked cabinet

Answer 26

FALSE outside of the pharmacy for emergencies, the PIC may grant pharmacy access for authorized individuals

Question 27

what can emergency kits contain?

Answer 27

non controlled and controlled drugs as long as the pharmacy supplying the controlled drugs complies with all the state and federal regulations

Question 28

who prepares, seals and stores the emergency kit in a secure location that only allows authorized access?

Answer 28

pharmacist

Question 29

the expiration date for a kit but be

Answer 29

the earliest expiration date of any drug within the kit

Question 30

when the kit expires, the pharmacist must dispose of the emergency kit

Answer 30

false | replace the expired drug and updates the kit's expiration date

Question 31

how is a drug removed from the emergency kit?

Answer 31

valid order in the chart order the supplying pharmacy must be notified anytime the emergency kit is OPENED - the pharmacy will then restock and reseal the kit

Question 32

a label must be on the outside of the kit to designate it as an emergency kit - what is on the label?

Answer 32

each drug name, strength, quantity expiration date and contents name, address, and phone number of the supplying pharmacy

Question 33

The ___ permits retail pharmacies to install automated dispensing systems in LTCFs in order to remotely dispense non controlled and controlled substances

Answer 33

DEA - examples: Omnicell, pyxis

Question 34

the drugs stocked in the ADS at the LTCF- is this considered pharmacy stock or LTCF?

Answer 34

pharmacy stock

Question 35

the pharmacy does not need a separate DEA registration for the ADS located at the LTCF

Answer 35

false, they do

Question 36

What can pharmacists perform using telemedicine?

Answer 36

remote order verification, ADSs, videoconferencing, verify rx, perform DUR, counsel patients

Question 37

what is the most common error made by pharmacists?

Answer 37

giving the wrong drug to the patient

Question 38

when a medication error occurs, an investigation called ___ should be performed

Answer 38

root cause analysis

Question 39

NABP recommends that the investigation be initiated within __ days of the incited (some states may have more stringent requirements of one or two days)

Answer 39

three

Question 40

what is the goal of the peer review process?

Answer 40

to prevent negative events from occurring; should occur periodically

Question 41

The peer review process will vary between states, but the following steps are recommended to facilitate its development

Answer 41

select members for the peer review committee set quality standards develop reporting procedures evaluate activities against the standards make recommendations based on evaluations conduct self audits

Question 42

The FDA regulates pharmaceutical quality through the use of

Answer 42

CGMPs - these are standards that manufacturers, repackagers and pharmacies must comply with to ensure the identity, strength, quality, and purity of products

Question 43

any drug produced in a manufacturing facility that does not meet CGMPs is considered ______ by law and should not be purchased by a pharmacy or distributed to patients

Answer 43

adulterated

Question 44

The DSCA applies to _____ drugs, intended for ______ use

Answer 44

prescription human

Question 45

there are three types of records that must accompany all drug transfers:

Answer 45

transaction information transaction history transaction statement must be maintained for at LEAST six years from the date of transaction!!!!************** electronic or paper

Question 46

the pharmacy department must have a clean, secure space with proper lighting and ventilation. Humidity and temp in the storage and dispensing areas should be maintained according to manufacturer

Answer 46

true

Question 47

fridge and freezer temps should be documented at LEAST ___ daily

Answer 47

once daily

Question 48

any drug that is not kept under proper conditions is considered ____ and must be removed from the normal drug stock and placed in a quarantined area

Answer 48

adulerated

Question 49

the DEA requires schedule II drugs to be stored in a securely locked _______ or ______ which cannot be easily broken into

Answer 49

locked cabinet or vault

Question 50

how can schedule III-V be stored?

Answer 50

1) in a securely locked cabinet, vault, cage, or building with perimeter security which cannot be easily broken into (can be with schedule II) 2) partially concealed by dispensing throughout the stock of non-controlled drugs with approval from the DEA office

Question 51

_________ drugs must be stored in a location that has limited access and in accordance with any specific instructions

Answer 51

investigational documentation should be maintained for each transport, handling, and receipt of study drugs

Question 52

drug samples can only be distributed to

Answer 52

prescribers hospital pharmacy healthcare entity at the written request of dr [excludes retail pharmacies]

Question 53

the manufacturer must label any sample drugs with a ____________ and a statement indicating that the product is a drug sample

Answer 53

a lot or control number

Question 54

written requests for drug samples must be maintained by

Answer 54

the manufacturer or distributor for THREE years

Question 55

what is a class I recall?

Answer 55

reasonable probability that the use of or exposure to the drug will cause SEIROUS adverse health consequences or death.

Question 56

Class II recall?

Answer 56

use of or exposure to the drug can cause temporary or reversible adverse health consequences

Question 57

Class III recall?

Answer 57

use of or exposure to the drug is not likely to cause adverse health consequences

Question 58

federal, state, or local law can request that a recall is carried out, but ultimately who issues the recall?

Answer 58

FDA or manufacturer

Question 59

who is responsible for notifying its CUSTOMERS (distributers and patients)

Answer 59

manufacturer

Question 60

if notification is sent ny mail, the envelope should be marked with words...

Answer 60

DRUG RECALL; URGENT, should also appear on the letter and the envelope for class I and II recalls.

Question 61

If a class I recall occurs, the pharmacist must identify patients who may have received the recalled drug. who is responsible for notifying each patient's prescriber and must keep a record of the notifications?

Answer 61

rph *some states may also require pharmacist to notify patient

Question 62

federal law requires that the pharmacy keep drug recall written documentation for at least

Answer 62

2 years (some states may require longer)

Question 63

when mailing medications, what should the packaging look like?

Answer 63

the outside packaging - should not have any identifying marks inner labeling - include information required under federal and state laws

Question 64

if an employee is delivering a medication and can't find the patients home.. can it be returned to stock?

Answer 64

yes never left the control of the pharmacy remained in the original seal package been returned to the pharmacy on the same day

Question 65

US postal service regulations permit pharmacies to deliver controlled substance to patients IF they are...

Answer 65

registered or exempt with the DEA

Question 66

what must be met to ship a controlled substance?

Answer 66

the prescription label contains the name and address of the dispenser (pharmacy or prescriber) the inner container is marked and sealed as required by law and is placed in an outer container the outside wrapper or container is free of marking that could indicate contents

Question 67

what are drugs that are not safe to deliver by tube at any time?

Answer 67

hazardous compounds (chemo) combustible products (gels, sprays) protein products (insulin, IVIG) *each facility must develop guidelines in its P&P manual

Question 68

What are examples of reportable diseases or activities to the local department of health

Answer 68

potential terrorist events suspected physical abuse TB infection or treatment

Question 69

all states have laws regarding the mandatory reporting of suspected

Answer 69

physical abuse