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)