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T or F. All pharmacies must have a PIC, even mail order. ✔✔True Define PIC ✔✔Pharmacist responsible for practice of pharmacy on Pharmacy's License Works w/in the physical confines *unless remote dispensing pharmacy* PIC duties ✔✔-Develop/implement *policies/procedures* (hosp) -Ensure that pharmacist *review medical orders* prior to first dose (with exceptions) (hosp) -Operational *Law Conformance* -Initial Inspection presence -File *Required Reports* -*Notify* Dept. of HHS and patients if pharmacy closing
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T or F. All pharmacies must have a PIC, even mail order. ✔✔True
Define PIC ✔✔Pharmacist responsible for practice of pharmacy on Pharmacy's License
Works w/in the physical confines unless remote dispensing pharmacy
PIC duties ✔✔-Develop/implement policies/procedures (hosp)
T or F. Pharmacist review is required of all medical orders prior to first dose being administered to patient in hospital. ✔✔T (with exceptions)
-STAT Orders (given immediately and ONCE)
-Harm to patient
Is telepharmacy allowed in hospitals to allow pharmacist review of orders? ✔✔Yes
When is pharmacist review of medical order not required in hospital? ✔✔When practitioner controls ordering/dispensing/administration of the drug
*OR
*Endoscopy suite
*ER
*Etc.
When time does not permit pharmacist review
*Stat order (x1)
*When status of patient would be significantly compromised by the delay
Do you need to send controlled substance inventories to anybody? ✔✔Forward to the Department
What to do if pharmacy ceases legal existence or discontinues business ✔✔Notify the Department within 15 days:
What to do if pharmacy has change of ownership ✔✔Notify the Department within 15 days
How to transfer schedule III-V medications (to a pharmacy, wholesaler, etc.) ✔✔Must be documented in writing
-Dosage form
-Strength
-quantity
-date transferred
-name/address/DEA# of parties involved
How do reverse distributors for controlled substances work? ✔✔-Pharmacy submits DEA 222 form/record of transfer (CIII-V)
-Reverse distributor files DEA 41 for destruction
Practice of Pharmacy definition ✔✔-Interpret/evaluate/implement medical orders
-Dispense drugs/devices
-Drug product selection
-Administration of drugs/devices
-DUR
-Counseling
-Provide pharmaceutical care
-MTM
Define unprofessional conduct ✔✔-Failure to practice adequately/ethically regardless of outcome
-Actions deceiving/defrauding public
-Actions detrimental to public interest
Can you prescribe a controlled substance to yourself? ✔✔No
Can you prescribe a controlled substance to family members, etc.? ✔✔Only in case of medical emergency
-spouse
-child
-parent
-sibling
-living in household
Can an employer or employer's agent coerce a pharmacist to dispense a drug product against the professional judgment of the pharmacist or as ordered by prescriber? ✔✔No
Define delegated dispensing ✔✔Joint, voluntary agreement to practice pharmacy with others under a protocol authorizing dispensing with specification of conditions/limitations
§38-2872 to §38-
Components of a delegated dispensing agreement ✔✔-Address
-Name/license # of each pharmacist
-Name/signature of other dispensers
-Inspection Procedures by delegated pharmacist
-Any other info required by the board
Not effective until permit issued by department with recommendation of the board
Define consultant pharmacist ✔✔*Actively
practicing NE RPH who holds an unrestricted license*
-designated on
the drug dispensing permit as the pharmacist who is responsible for dispensing requirements
-Notify clinic if won't be available during the required time-must be documented
Can dispensing occur in a public health clinic if there is no consultant pharmacist or on-call pharmacist? ✔✔No
Copy of initial inventories taken pursuant to a PIC change must be forwarded to the Dept. within ______ of completion ✔✔30 days
When a pharmacy goes out of business, the unused DEA 222
forms must be: ✔✔Returned to DHHS
-Includes forms A and D
A delegated dispensing agreement shall include what things: ✔✔-Address of dispensing site
-Name & License # of each RPH
-Name/Signature of each dispenser
-Inspection procedures
-Documentation of inspections
Q4: Which of the following activities is (are) the responsibility of a pharmacist-in-charge? (Select ALL that apply.)
A) Must be present for the initial on-site inspection
B) Notify patients of pharmacy closing
C) Annually submit a report to DEA of all CII sales
D) Annually submit a completed Pharmacy Quality Assurance
Report ✔✔A
B
D
What can pharmacy technicians NOT do? ✔✔-Take oral Rx's except for refills
-Counseling
-Evaluation/clarification of orders
-Supervision of other techs
-Interpretation/Evaluation of patient records
-Release confidential info
-Perform consultations
Tech registration requirements (timing) ✔✔Certified within 1 year of being registered by State or National Certifying Body (as of 1/1/16)
Tech registration requirements ✔✔-High school graduate or equivalent
-No Non-Alcohol drug related misdemeanors/felonies
-File application with Division of Public Health of DHHS
-Pay fee
Tech identification requirements ✔✔Must be identified as a pharmacy tech while performing tech duties
Define pharmacist intern (requirements for interns) ✔✔-Student/Graduate of accredited pharmacy program completing internship.
-Graduate of an unaccredited pharmacy program located outside the United States who has successfully passed equivalency
examinations approved by the board
How long is an intern license valid for? ✔✔15 months after graduation or at time of professional licensure
If based on graduation from non-accredited program, expires 15 months from date of issuance or at time of professional licensure
Components of intern application ✔✔-Name
-Place/DOB
-SSN
-Mailing Address
-Permanent Address
-Phone/email/fax (optional)
-Name/location of Pharm School
-Official documentation of month/year of enrollment and graduation
-Statement that must not practice w/o immediate supervision of licensed pharmacist
-Statement that all info is correct
-Fee
-Birth certificate/marriage license/driver's license/other age verification
Intern identification requirements ✔✔-Registration card at all times.
-Intern name tag, etc...
Q2: A pharmacy technician may perform all of the following duties EXCEPT:
A) Entering prescription data into a data processing system
B) Taking a new oral medical order from a prescriber
C) Receiving refill authorization requests
D) Reconstituting medications
E) Compounding sterile preparations of medications ✔✔B
Q3: A registered pharmacy technician shall: (Select ALL that apply.)
A) Be a high school graduate or be officially recognized by the State Department of Education as possessing the equivalent degree of education
B) Have never been convicted of any nonalcohol, drug-related
misdemeanor or felony
C) Become certified within a period of six months
D) Submit to a mandatory preliminary urine drug screen ✔✔A
B
Q4: Which of the following statements are TRUE according to Nebraska
Pharmacy Law? (Select ALL that apply.)
A) A pharmacist may supervise up to three pharmacy technicians at any time
B) A pharmacist may supervise up to three pharmacist interns at any time
C) A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people
D) Supervision ratios do not apply to pharmacist interns receiving experiential training
E) Ratios for pharmacist supervision of technicians and pharmacist interns are not explicitly defined ✔✔A
B
C
D
Q5: What combination of pharmacy employees is allowed by law?
A) One pharmacist, two technicians, and one student who is receiving experiential training, directed by their accredited school
B) One pharmacist, one intern, and three technicians
TRACK AND TRACE ✔✔-Provide product tracing information (lot-level)
-Handle suspect/illegitimate product: quarantine and investigate suspect product and notify FDA/immediate trading partners if illegitimate
-Confirm licensure of authorized trading partners
Can retail pharmacist receive or dispense prescription samples? ✔✔No - only starter packs
-Not considered samples, intended for initiation of therapy
Possession of prescription drug samples by retail pharmacies would be considered ___ by the FDA ✔✔Drug diversion
Can institutional pharmacies receive samples? ✔✔Yes, if
How to licensed practitioners get samples? ✔✔Provide written requiets
-drug manufacturer/distributor must keep requests for 3 years
Temperature requirements ✔✔Fridge: 36-46 F
Freezer: -4 to 14 F
Cool place: 46-59 F (or fridge)
Controlled room temp: 59-86 F
Can food be in fridge with drugs, etc.? ✔✔Must be in separate compartment
Requirements for storage of prescription inventory/prescription records ✔✔must be maintained in a secure location when there is no pharmacist on the premises. Loss of prescription inventory or
prescription records due to theft or any other cause resulting from failure to secure the inventory or records are grounds for
disciplinary action
Define distribute ✔✔Deliver drug/device other than by administration/dispensing
Does intracompany sale of prescription drugs constitute wholesale drug distribution? ✔✔No