Final Study Guide Flashcards
A child must be how old for a pharmacist to administer a vaccine?
7 y/o
Pharmacist must have an active ___ certification to administer vaccines
CPR
Under declared emergency, pharmacist may administer vaccines to children over?
3 y/o
within how many days does a vaccine need to be reported to OHA?
15 days
The Public Health and Pharmacy Formulary Advisory Committee shall consist of:
two licensed physicians
two advanced PRNs
three licensed pharmacists
Which of the following is true regarding Emergency Use Authorizations (EUA) used by the FDA to allow COVID-19 vaccines into the market for use?
a. Is a regulatory pathway that grants full drug approval when there is only safety information and not efficacy data
b. Cannot be revoked, updated, or changed upon FDA issuance
c. Requires approval by the executive branch of the federal government
d. A mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies
a
When the Board of Pharmacy finds that a licensee has a drug or alcohol dependence problem, in addition to possible disciplinary action, the Board may recommend enrollment in:
a. Pharmacy Recovery Network
b. Health Professional’s Service Program
c. Professional Recovery Network
d. Alcoholics Anonymous
e. Narcotics Anonymous
b
how do you define a “drug utilization review”?
when the pharmacist evaluates a prescription using the information provided by the patient or patient’s agent and the information in the patient’s record to promote therapeutic appropriateness by identifying potential problems.
what was the Sherman Antitrust Act?
what was the main goal?
Prohibits competitors from entering into agreements that inhibit competition
help markets remain competitive and keep prices low via competition
what was the Robinson-Patman Act?
prevent discriminatory pricing to similar competitors
what was the main impact of the Durham-Humphrey Amendment to the Food Drug and Cosmetic Act?
establishment of OTC category of drugs (created two categories of drugs: prescription and OTC)
what was the main impact of the Kefauver-Harris Amendment to the Food Drug and Cosmetic Act?
required proof of safety and efficacy and established GMPs
what was the main impact of the Waxman-Hatch Amendment (aka Drug Price Competition and Patent-Term Restoration Act) to the Food Drug and Cosmetic Act?
accelerated the generic drug approval process
what was the main impact of the Prescription Drug User Fee Act (PDUFA) to the Food Drug and Cosmetic Act?
drug manufacturers pay fees for product applications to fund FDA reviewers and speed up review/approval
what was the main impact of the Dietary Supplement Health & Education Act (DSHEA) to the Food Drug and Cosmetic Act?
- establish specific labeling requirements
- authorize FDA to pass GMP regulations for dietary supps.
- manufacturer is responsible for dietary supp. safety before marketing (FDA approval not required)
what was the main impact of the Food and Drug Administration Modernization Act (FDAMA) to the Food Drug and Cosmetic Act?
fast-track drug approval for serious diseases and regulate advertising of approved drugs & devices
The process of ____________ is a distinct service or group of services intended to optimize the therapeutic outcomes of a patient. It can be an independent service provided by a pharmacist or can be in conjunction with the provision of a medication product.
a. Collaborative Drug Therapy Management
b. Drug utilization review
c. Quality assurance
d. Counseling
e. Medication Therapy Management
e
Pharmacies outside of Oregon that produce compounded pharmaceutical products and sell those products to pharmacies and clinics in Oregon must register with the Oregon Board of Pharmacy as a:
a. Wholesaler
b. Manufacturer
c. Dispensing Practitioner Drug Outlet
d. Retail Drug Outlet
e. Institutional Drug Outlet
b
Which of the following is NOT required to be on the label of a prescription medication bottle filled by a pharmacist in Oregon?
a. Name, address and telephone number of the pharmacy
b. Directions for use by the patient
c. National Drug Code (NDC)
d. Name of the practitioner
e. Name of the patient
c
If a graduate of the OSU/OHSU College of Pharmacy wishes to pursue a residency program in another state and would like to obtain a pharmacist license in Oregon and the other state, which of the following would be the most efficient and least costly way to accomplish that goal?
a. the reciprocity process through NABP
b. take and pass the NAPLEX once in each state
c. MPJE score transfer
d. NAPLEX score transfer
e. take and pass the FPGEE
d
define a Traditional Pharmacy-practice Internship
working as an intern with pay not associated with school
What effect did the 1984 Drug Price Competition and Patent-Term Restoration Act have on the practice of pharmacy?
a. Increased funding of the FDA by imposing user fees on manufacturers
b. Increased competition between hospital and retail pharmacies
c. Increased the availability of generic drugs
d. Required drug manufacturers to provide proof of efficacy
e. Allowed substitution of biosimilar products
c
what is a mechanical error?
wrong drug, strength, or directions dispensed
what is an intellectual error?
Errors made based on a decision made by the pharmacist
