RX PREP Chapter 3: Pharmacy Operations Flashcards
foreign trained pharmacists must complete the ____ by passing the FPGEE and the TOEFL
FPGEC; once complete, also have to complete the state’s required internship hours
what type of pharmacist has prescriptive authroity?
clinical pharmacist practitioner or advanced practice pharmacist
What are the two primary certification exams for the pharmacy technician certification board?
pharmacy technician certification examination
exCPT pharmacy technician certification exam
description: license is restricted for a specified period of time
action: probation
description: license is inactivated; it may be reinstated after conditions are met
suspension
description: license is taken away by the licensing agency
revocation
individual agrees to voluntarily give up license often under pressure to avoid penalties and or criminal charges
surrender
license that lapsed, was suspended or revoked is returned to active status authoring practice as defined by that license
reinstatment
what are the most common causes of disciplinary action?
impairment, drug theft, and drug diversion
who has the final authority over disciplinary proceedings?
the board
law enforcement can be involved
when applying to open a pharmacy, what is often required as part of the licensing application?
- the physical address
- classification (community, hospital, speciality)
- name and license # of PIC
- fee
- NPI # for pharmacy
after initial approval of the pharmacy, the DEA will send a registration renewal notice to the registrant ___ days prior to the expiration
60 days
for out of state and mail order pharmacies, should the pharmacy or pharmcist be licensed?
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
for pharmacy inspection, the items inspected commonly include
record keeping systems
compliance with the controlled substance act
temperature logs for fridge
the pharmacy space must be secured by
a physical and or electronic barrier
in the event that the prescription information is permanently lost due to a power outage, the board of pharmacy should be notified within __ hours
24h
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
96h
What are the records that MUST be kept by pharmacies?
-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
an _____ facility provides a physical location for patients to receive extended healthcare services
institutional (hospitals, assisted living facilities, LTCF, nursing homes, rehab center, drug abuse treatment centers)
an ____ pharmacy provides pharmacy services to any institutional facility and may or may not be physically attached to the facility
institutional
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
nurse
a valid prescription drug order in an institutional facility is called a _____ or _______
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
T/F
chart orders are exempt from the standard prescription requirement
true
what must a chart order include?
patient name
date of issue
drug name, strength, dosage form
directions of use
prescriber signature
T/F
a pharmacy within an institutional facility may be without a pharmacist for designated periods of time
true
- the pic must have procedures in place for authorized individuals to obtain medications and there must be a pharmacist on call during absence
a supply of drugs should be available inside the pharmacy in a locked cabinet
FALSE
outside of the pharmacy
for emergencies, the PIC may grant pharmacy access for authorized individuals
what can emergency kits contain?
non controlled and controlled drugs as long as the pharmacy supplying the controlled drugs complies with all the state and federal regulations
who prepares, seals and stores the emergency kit in a secure location that only allows authorized access?
pharmacist
the expiration date for a kit but be
the earliest expiration date of any drug within the kit
when the kit expires, the pharmacist must dispose of the emergency kit
false
replace the expired drug and updates the kit’s expiration date
how is a drug removed from the emergency kit?
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
a label must be on the outside of the kit to designate it as an emergency kit - what is on the label?
each drug name, strength, quantity
expiration date and contents
name, address, and phone number of the supplying pharmacy
The ___ permits retail pharmacies to install automated dispensing systems in LTCFs in order to remotely dispense non controlled and controlled substances
DEA
- examples: Omnicell, pyxis
the drugs stocked in the ADS at the LTCF- is this considered pharmacy stock or LTCF?
pharmacy stock
the pharmacy does not need a separate DEA registration for the ADS located at the LTCF
false, they do
What can pharmacists perform using telemedicine?
remote order verification, ADSs, videoconferencing, verify rx, perform DUR, counsel patients
what is the most common error made by pharmacists?
giving the wrong drug to the patient
when a medication error occurs, an investigation called ___ should be performed
root cause analysis
NABP recommends that the investigation be initiated within __ days of the incited (some states may have more stringent requirements of one or two days)
three
what is the goal of the peer review process?
to prevent negative events from occurring; should occur periodically
The peer review process will vary between states, but the following steps are recommended to facilitate its development
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
The FDA regulates pharmaceutical quality through the use of
CGMPs
- these are standards that manufacturers, repackagers and pharmacies must comply with to ensure the identity, strength, quality, and purity of products
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
adulterated
The DSCA applies to _____ drugs, intended for ______ use
prescription
human
there are three types of records that must accompany all drug transfers:
transaction information
transaction history
transaction statement
must be maintained for at LEAST six years from the date of transaction!!!!**** electronic or paper
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
true
fridge and freezer temps should be documented at LEAST ___ daily
once daily
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
adulerated
the DEA requires schedule II drugs to be stored in a securely locked _______ or ______ which cannot be easily broken into
locked cabinet or vault
how can schedule III-V be stored?
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
_________ drugs must be stored in a location that has limited access and in accordance with any specific instructions
investigational
documentation should be maintained for each transport, handling, and receipt of study drugs
drug samples can only be distributed to
prescribers
hospital pharmacy
healthcare entity at the written request of dr [excludes retail pharmacies]
the manufacturer must label any sample drugs with a ____________ and a statement indicating that the product is a drug sample
a lot or control number
written requests for drug samples must be maintained by
the manufacturer or distributor for THREE years
what is a class I recall?
reasonable probability that the use of or exposure to the drug will cause SEIROUS adverse health consequences or death.
Class II recall?
use of or exposure to the drug can cause temporary or reversible adverse health consequences
Class III recall?
use of or exposure to the drug is not likely to cause adverse health consequences
federal, state, or local law can request that a recall is carried out, but ultimately who issues the recall?
FDA or manufacturer
who is responsible for notifying its CUSTOMERS (distributers and patients)
manufacturer
if notification is sent ny mail, the envelope should be marked with words…
DRUG RECALL; URGENT, should also appear on the letter and the envelope for class I and II recalls.
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?
rph
*some states may also require pharmacist to notify patient
federal law requires that the pharmacy keep drug recall written documentation for at least
2 years (some states may require longer)
when mailing medications, what should the packaging look like?
the outside packaging - should not have any identifying marks
inner labeling - include information required under federal and state laws
if an employee is delivering a medication and can’t find the patients home.. can it be returned to stock?
yes
never left the control of the pharmacy
remained in the original seal package
been returned to the pharmacy on the same day
US postal service regulations permit pharmacies to deliver controlled substance to patients IF they are…
registered or exempt with the DEA
what must be met to ship a controlled substance?
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
what are drugs that are not safe to deliver by tube at any time?
hazardous compounds (chemo)
combustible products (gels, sprays)
protein products (insulin, IVIG)
*each facility must develop guidelines in its P&P manual
What are examples of reportable diseases or activities to the local department of health
potential terrorist events
suspected physical abuse
TB infection or treatment
all states have laws regarding the mandatory reporting of suspected
physical abuse
