Exam

Question 1

The BOP regulates the ________ and ________ of drugs

Answer 1

manufacture, distribution

Question 2

what qualifications must be met by the PIC in a pharmacy?
Must have complete one year of pharmacy practice and a board-provided PIC training course within ____ days.
They must complete a board provided PIC training course at least every __ years
A PIC cannot be designated to more than __ pharmacies

Answer 2

90
5
3

Question 3

what responsibilities must be met by the PIC in a pharmacy?
must be _______ at the pharmacy on a regular basis.
ensure, maintain, and enforce a continuous __ program.
Complete an annual self-inspection of the pharmacy by ____ of each year and within ____ days of becoming PIC.
The self-inspection must be signed and dated by the PIC and retained for ______ years from the date of completion.
controlled inventory count at least every _____ days.
CII drugs counted at least every ___ days in retail pharmacies, and ____ days in institutional pharmacies

Answer 3

present
QI
July 1st, 15
3
367
93, 31

Question 4

How must prescription drug containers be labeled, and what information must they include?

Answer 4

name, strength, name of provider, name and place of business of the pharmacy, the patients name, expiration date, and physical description of the drug

Question 5

Define misbranding and explain how it applies to pharmaceutical products:
a package is misbranded if its ________ is false or misleading or does not provide the name of the _______, accurate statement of the ______ of the drug, or adequate directions/warnings

Answer 5

labeling, manufacturer, quantity

Question 6

What is drug substitution, and under what circumstances can it occur?
what sources can we use to find correct drug substitutions?

Answer 6

if the drug is therapeutically equivalent
orange book for chemical drug equivalents and purple book for biologic equivalents

Question 7

biological products may be substituted if the pharmacy retains a record of the substitution for a period of __ years

Answer 7

3

Question 8

Describe the licensing requirements for pharmacy technicians, pharmacists and interns.
CE Requirements:
Pharmacists: ____ hours
techs: ____ hours
interns: ___ hours

Answer 8

30
20
2

Question 9

what is a RDSP affiliated pharmacy?

Answer 9

a retail drug outlet pharmacy where the pharmacist provides pharmacy services through a telepharmacy system.

Question 10

what is a RDSP?

Answer 10

Remote Dispensing Site Pharmacy: remote retail drug outlet using a telepharmacy system

Question 11

Prescriptions for controlled substances can only be transferred ____.

Answer 11

once

Question 12

Prescriptions must be transferred once the request is received from another pharmacy by?

Answer 12

the end of the next business day

Question 13

What are the requirements for an out-of-state prescription to be filled by an Oregon pharmacist?
A prescription written by a practitioner licensed in a state other than Oregon may be filled only if the pharmacist determines that it was issued pursuant to a valid patient-practitioner relationship and that it is authentic. If the practitioner prescribing the script is not known to the pharmacist, the pharmacist shall obtain proof to a reasonable certainty of the ____ of the prescription.

Answer 13

validity

Question 14

What are the responsibilities of a Chief Pharmacy Officer in a hospital pharmacy?
The CPO must specify the responsibilities of the CPO and PIC if separate individuals hold these positions.
The CPO must establish policies and procedures that include:
Procedures for general distribution of drugs throughout the hospital, a procedure for review and revision of the policies and procedures not less than every __ years, procedures from the supervision of the pharmacy services including storage, distribution, control and accountability for drugs including controlleds, procedure to ensure that all areas of the hospital where drugs are stored are inspected not less than every __ months, procedures that govern preparation, verification and sterilization of parenteral drugs compounded within the hospital, procedures for administration of drugs, procedures for labeling, policies and procedures that govern the filling and labeling of containers from which drugs are to be administered, procedures for quality assurance, emergency drug distribution, procedures for procurement of all drugs subject to approval of the appropriate committee of the hospital, procedures that ensure discontinued, outdated, adulterated or misbranded drugs are returned to the pharmacy for proper disposition, recall procedure that can be quickly activated, policies and procedures for the use of investigational drugs, and procedures to be followed in the absence of the pharmacist.

Answer 14

3, 2

Question 15

What information must be included on pre-packed medication?

Answer 15

drug name
expiration
manufacturer name and lot number
strength of drug

Question 16

T/F controlled substances may not be returned

Answer 16

true

Question 17

When is it allowed for a drug to be returned (usually by the patient) to the pharmacy?

Answer 17

drugs are accepted for destruction and disposal
the drug had dispensing errors or hazardous to the patient

Question 18

when can returned drugs be re-dispensed?

Answer 18

drug is tamper-proof and unopened
drug was with a person trained in storage and administration of drugs

Question 19

What are the regulations and considerations for Automated Dispensing Machines (ADMs) in hospital settings? Hint: ADMs and kiosks are the same thing (the law will probably be changed in the next year or two to call these all kiosks):
The CPO or PIC and appropriate hospital committee will establish a limited selection and quantity of drugs to be included in the emergency department formulary and the amount contained in each pre-pack that may be distributed to meet only the acute care needs for a patient; for example, an emergency supply of drugs. The amount dispensed may not exceed a 48 hour supply except for:
A drug in the manufacturer’s unit of use packaging such as an inhalant or a topical drug
A full course of therapy such as an antibiotic
Any additional prep for the medication must be done (reconstitution)
An ADM may only be located within the ___ in a secure environment that has no direct public access, and when used, must be a part of the discharge procedure.
A _____________ must be present at the time of dispensing and will grant access to the ADM for the release of the drugs to be dispensed using password protection.
Only a ________________ may access the drug supply in the ADM.

Answer 19

ED
RN, practitioner, or pharmacist
pharmacy technician, intern, or pharmacist

Question 20

Understand the circumstances under which civil penalties can be imposed by the State Board of Pharmacy.
A civil penalty may not exceed _______ for each violation by an individual and _______ for each violation by a drug outlet.

Answer 20

$1000, $10,000

Question 21

Understand the process that a pharmacist goes through if they have a substance use disorder and are disciplined by the board of pharmacy including the Health Professionals Service Program

Answer 21

Licensee must be proven to have a substance use disorder. Must enroll in the program for at least 2 years, meet all conditions of probation, and pay cost of all attendance

Question 22

A licensee in a substance use disorder program can petition for early removal of the program if?

Answer 22

theyve been in the program for at least 2 years and have complied with all conditions

Question 23

Know the definition of Clinical Pharmacy Agreement and Collaborate Drug Therapy Management and the difference between the two

Answer 23

clinical pharmacy agreement is between pharmacist and organization or physician that allows the pharmacist to practice clinical pharmacy. Collaborate Drug Therapy Management is a collaboration b/w pharmacist and physician allowing pharmacists to adjust or manage a drug regimen.
CDTMs are based on agreed-upon protocols for specific disease indications. So a specific drug is used per protocol for a disease. CPAs are a broader authority for pharmacists to participate in developing the plan for treatment for a patient’s disease state.

Question 24

A Collaborate Drug Therapy Management must be reviewed and updated or discontinued at least every __ years

Answer 24

2

Question 25

What is the PDMP and when do you need to report? Who needs to report? Who pays for it?
report no later than ___ hours after dispensing a controlled substance. a ______ shall electronically report to the authority.
it is paid for by _______ fees

Answer 25

72
pharmacy
licensing

Question 26

What is the Pharmacy Formulary Advisory Committee and what do they do?

Answer 26

PHPFAC makes recommendations regarding what a pharmacist can prescribe and creates the formulary and protocols.

Question 27

what can pharmacists prescribe for coughing?

Answer 27

benzonatate

Question 28

what can pharmacists prescribe for asthma?

Answer 28

albuterol

Question 29

what can pharmacists prescribe for vulvovaginal candidiasis?

Answer 29

fluconazole

Question 30

what is a class I recall?
class II?
class III?

Answer 30

class I: product can cause serious harm or death
class II:product could cause significant injury or temporary illness
class III: product unlikely to cause injury or illness but violate FDA regulations