Ch 3: Pharmacy Operations Flashcards
FED Foreign-trained rphs must complete the Foreign Pharmacy Graduate Examination Committee Certification by passing what?
the FOreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language (TOEFL)
FED T/F Foreign-trained rphs are required to complete the same amount of internship hours as US-trained rphs
Depends. They may have to complete more
NABP stands for
National Association of Boards of Pharmacy
FED All 50 states as well as which places participate in NAPLEX score transfer program
All 50 US states as well as:
1) District of Columbia
2) Guam
3) Puerto Rico
4) Virgin Islands
FED Max of how many days after taking NAPLEX to request score transfer
89 days
FED When requesting reciprocity, which organization facilitates the transfer, and which org decides if a license is granted
NABP facilitates transfer
individual state BOP will decide if license granted
CPE hours stands for
Continuing Pharmacy Education hours
FED T/F CPE hours can only be completed in live sessions, aside from during COVID19
False. CPE hours can be live, or by mail/internet. Some states may require some hours to be live.
FED Which type of CPE hours can be rolled over to the following year if they are in excess
Most states do NOT permit excess CPE hours to be rolled over
FED The first formal technician training programs were developed in hospitals by the ___
ASHP = American Society of Health-system Pharmacists
FED Name the two primary certification exams for technicians
PTCB = Pharmacy Technician Certification Examination NHA = ExCPT Pharmacy Technician Certification Exam
FED Select all that apply: pharmacists may still practice under the following license statuses:
1) Probation
2) Suspension
3) Revocation
4) Surrender
5) Reinstatement
1) Probation (can practice under another RPh or something)
2) Reinstatement
FED T/F License suspension is usually permanent, and also indefinite
False. License REVOCATION is usually permanent, but also indefinite
FED 3 most common causes of disciplinary action against pharmacy staff
Impairment, drug theft, drug diversion
FED Describe the difference between drug theft and drug diversion
Theft = stealing from the store (pocketing a bottle) Diversion = replacing patient's meds, and pocketing their intended meds
FED To which jurisdictions are you required to report disciplinary action of your license to
Required to report to all jurisdictions in which you are licensed
FED In the process of opening a pharmacy, a permit shall be required from:
1) the state
2) the FDA
3) the DEA
First step is to obtain a pharmacy license (aka a permit) from the state, THEN, subsequently, with the DEA if controlled substances are involved
FED T/F To open a pharmacy, one must first register with the DEA, then apply for a pharmacy license/permit from the state
No. First step is to obtain pharmacy license/permit from the state. Then register with DEA if involves controlled substances
FED Pharmacies dispensing controlled substances should have these 2 requirements
1) valid DEA registration (unless exempt)
2) meet PDMP requirements when applicable
FED A facility that stores and distributes prescription drugs should comply with the standards set by
USP, at minimum
FED If sterile medications are prepared, they must be prepared in a:
Laminar flow hood, AND/OR biological safety cabinet…. might be more info in compounding chapter tho
FED T/F Federal law requires current drug information resources to be available at every pharmacy
False. There are no federal requirements
FED In the event that prescription information is permanently lost, the BOP should be notified within (federal)
24 hours
FED If a pharmacy should relocate and need to move the location of controlled substances, the ___ requires a change of address form for the registrant
DEA
FED P&P stands for
Policy & Procedures
FED Three types of information that satisfy the requirements of the Drug Supply Chain Security Act in terms of all drugs purchased and received by the pharmacy
Transaction information (TI) Transaction history (TH) Transaction statement (TS)
FED A valid prescription drug order in an institutional facility is called
a chart order, or a medication order
FED T/F Federal: once a chart order is is entered, it is automatically deactivated after 28 days
False. Once entered, it remains ongoing/active until a date (if specified), or it is discontinued
FED A chart order/medication order must contain
1) patient name
2) date of issue
3) drug name, strength, and dosage form
4) directions for use
5) prescribers signature, or signature of pts licensed health care designee along w the prescribers name
FED T/F In an institutional pharmacy, a nurse or other healthcare provider must be on call if a pharmacist is not on duty
False. A pharmacist must be on call during any absence
FED T/F In emergencies in institutional facilities, the on-call pharmacist may grant pharmacy access for authorized individuals
False. Only the PIC may grant pharmacy access to authorized individuals in emergencies
FED Select all. A drug can be removed from an e-kit if:
1) the PIC grants access to an authorized individual
2) a valid chart order is received
3) the pharmacist on-call grants emergency access
A drug can only be removed from the e-kit with a valid chart order
FED Name the labeling requirements for an e-kit
1) Each drug name, strength, and quantity
2) Expiration date of contents/kit
3) Name, address, phone # of supplying pharmacy
* DOES NOT contain prescriber/pt info**
FED T/F If a retail pharmacy installs and ADC in a LTCF, the contents of such ADC are then considered LTCF stock
False. An ADC installed by a retail pharmacy into a LTCF is still considered PHARMACY stock, not LTCF stock
FED T/F If a pharmacy is to place an ADS at a LTCF, a separate DEA registration is required for such ADS
True
FED Select all: The P&P manual serves to:
1) Educate employees on procedures
2) Educate patients on pharmacy practices such as lunch hours
3) Protect the pharmacy in cases of litigation
4) May be required for state/insurance reimbursements
5) Is required under USP to be accessible in a quick fashion
P&P serves to:
- Educate employees
- Protect in cases of litigation
- May be required for state/ins reimbursements
- Explains “what to do” in various circumstances
FED Most common pharmacy error
Giving wrong drug to a patient
FED NABP recommends initiating CQI after a medication error in what time frame
Within 3 days
FED NABP recommends pharmacy conducts a self-audit at least ____ to assess frequency of med errors
Quarterly = every 3 months
FED NABP recommends each pharmacy conduct a survey of the customers (or sampling) at least ___ to determine patient perception of the pharmacys quality
annually
FED who regulates pharmaceutical quality through CGMPs?
FDA
FED A drug made in a facility that doesn't meet CGMPs is considered: A) Misbranded B) Adulterated C) A B-rated drug D) Raw material
Adulterated
FED What act in 2013 was passed to outline steps to build a system to track and trace Rx drugs for human use throughout the US
Drug Supply Chain Security Act (DSCSA)
FED Select all. Which of the following products does the DSCSA apply to?
1) Oxygen
2) Homeopathic preparations
3) Radioactive drugs
4) OTC drugs
5) Prescription drugs
5) Rx drugs
The DSCSA only applies to prescription drugs intended for human use. Does NOT apply to many things
FED Select all. Which os the following products does the DSCSA apply to?
1) Active pharmaceutical ingredients
2) Prescription medications
3) Pediatric prescription medications
4) IV contrast for imaging
5) Dialysis products
Prescription medications, pedi Rx meds
Does NOT APPLY to the others…. including active pharmaceutical ingredients!
FED What 3 types of records must accompany all drug transfers under the DSCSA?
1) transaction information = TI
2) transaction history = TH
3) transaction statement = TS
FED Select all. Which of the following are exempt from maintaining the TI/TH/TS records for 6 years under the DSCSA?
1) Moving drugs from the wholesaler to the pharmacy
2) Dispensing drugs to a patient
3) Disposing of drugs to be destroyed
4) Distributing drug samples
5) Moving drugs to a doctors office to be administered to patients in the office
EXEMPT ARE:
- Dispensing drugs to a patient
- Providing drugs to practitioner for office use
- Distributing drug samples
FED TH, TS, and TI should be kept for a minimum of ___ years from what point in time?
6 years from the date of the transaction
FED USP-NF defines controlled room temperate as
68-77 F
FED Fridge and freezer temps should be documented how often in the log book?
At least once daily
FED Select all. What should be done with adulterated drugs?
1) They should be labeled appropriately
2) They should be quarantined
3) They should be marked as hazardous waste
4) They should be stored in a yellow bag
They should be quarantined = stored in a separate area for storage and utlimate disposal
They should be albeled appropriately to avoid accidental dispensing
FED Under what 5 scenarios must be drugs be quarantined?
ICARE: Investigational, Counterfeit, Adulterated, Recalled, Expired
FED Select all. Which of the following drugs may be stored by dispersing among the stock of non-controlled drugs, with approval from the local DEA office?
1) Ambien
2) Tylenol #3
3) Fioricet
4) Vyvanse
5) Promethazine
6) An investigational drug
All except investigational drugs. Investigational drugs need to be quarantined from other drug stock
FED T/F CII drugs can be stored dispersed among pharmacy stock of non-controlled drugs
True, as of October 2020, this was an update
FED How much investigation drugs be stored?
Quarantined, in a location with limited access
FED Documentation for investigational study drugs should include for each of these 3 steps
Transport, handling, and receipt of study drugs
FED Which of the following prohibits the sale of expired prescription and non-prescription drugs?
1) PDUFA
2) DSCSA
3) FDCA
4) Durham-Humphrey amendment
FDCA
FED What act regulates the distribution of drug samples?
PDMA
FED To whom can drug samples NOT be distributed to?
1) Prescribers
2) Hospital pharmacies
3) Healthcare entities at the request of a prescriber
4) Retail pharmacies
4) Retail pharmacies
“Healthcare entity” is written to specifically EXCLUDE retail pharmacies
FED T/F Retail pharmacies are permitted to stock and dispense drug samples if registered with the local DEA
False, retail pharm are not permitted to stock or dispense drug samples
FED 2 labeling requirements for drug samples
1) lot or control number
2) statement indicating this is a drug sample
FED Written requests for drug samples must be maintained by the manufacturer or distributor for at least:
1) 1 year
2) 2 years
3) 3 years
4) 6 years
3 years
FED Drug samples are to be stored where?
Separate from other drug inventory
FED What class of recall would a fentanyl patch containing 50 mcg instead of 10 mcg be classified as?
Class I recall
FED A drug recalled for containing NDMA would be what class of recall?
Class II recall
FED A drug recalled for failing dissolution tests would be what class of recall?
Class III recall
FED Select all. Drug recalls are ultimately issued by:
1) State enforcement
2) DEA
3) FDA
4) Drug manufacturer
FDA or drug manufacturer, though the state or local law enforcement can request that a recall is carried out
FED Who is ultimately responsible for notifying customers, including distributors and patients, or recalled drugs?
1) The PIC
2) FDA
3) DEA
4) Manufacturer
Manufacturer
FED Select all. If a drug recall notice for a Class III recall is to be mailed, what should the envelope be marked with?
1) DRUG RECALL
2) URGENT
3) TO BE OPENED IMMEDIATELY
Class III = least bad = marked only with DRUG RECALL. If it was Class I/II should also say URGENT
FED Select all. If a Class I recall occurs, the pharmacist is responsible for:
1) Identifying patients
2) Notifying patients
3) Notifying prescribers
4) Keeping a record of patients notified
5) Keeping a record of each prescriber notified
If a Class I recall occurs, the RPh must IDENTIFY patients who have received the recalled drug, NOTIFY each patients prescriber, and keep a RECORD of these notifications
FED Documents on the disposition of recalled drugs should be kept for at least how many years?
2 years = think there are 2 L’s in recalled, 2 years
FED In some cases, an RPh may deliver a medication directly to a patient. In the event the delivery is unable to be made, the medication can be returned to stock if:
1) It is returned to the pharmacy within 24 hours of attempted delivery time
2) It is returned to the pharmacy on the same day as the unsuccessful delivery attempt
3) Up to expiration as long as the package seal is intact
2 = must be the same day, can’t sit in their car overnight
FED T/F The US Postal Service permits pharmacies to deliver controlled substances as long as they are registered or exempt with the DEA
True
FED T/F Some kiosks allow patients to insert a written prescription and leave with their medication
True. Some kiosks allow pts to insert written Rx, have it verified by RPh, and leave with their meds
FED A kiosk for dispensing prescriptions is maintained by:
1) Local DEA
2) State BOP
3) A pharmacy
4) Drug manufacturer
A pharmacy
FED Select all. Which of the follow drugs are able to be sent by vacuum tube?
1) Doxorubicin
2) NTG spray
3) Latanoprost solution
4) Insulin
5) Suboxone strips
Latanoprost and suboxone
Dont tube: hazardous compounds, chemotherapy, combustibles (some gels and sprays), protein products (insulin, immunoglobulins)
FED T/F Pharmacists are mandatory reporters of suspected physical abuse in all jurisdictions
False, they are mandatory reporters in most states
FED T/F Federal law mandates that each state have laws regarding the mandatory reporting of child abuse/neglect and elder abuse
False, some states MAY include elder abuse
