Pharmacy Quality Assurance (Domain 5) Flashcards
What is the meaning of the acronym “SOP”?
Standard Operating Procedure
What is the meaning of the acronym “TQM”?
Total Quality Management
Who developed the “Error-Prone Abbreviations List”?
ISMP
What is the meaning of the abbreviation “ACPE”?
American College of Pharmacy Education
What is the meaning of the acronym “PTCB”?
Pharmacy Technician Certification Board
Who developed the “High Alert Medication List”?
ISMP
Who oversees the practice of pharmacy in a state?
State Board of Pharmacy
What is the meaning of the acronym “PTEC”?
Pharmacy Technician Educators Council
What is the meaning of the acronym “APhA”?
American Pharmaceutical Association
What is the meaning of the abbreviation “ASHP”?
American Society of Health-System Pharmacists
What is the meaning of the acronym “USP”?
United States Pharmacopeia
What is the meaning of the acronym “CDC”?
Centers for Disease Control
What is the meaning of the abbreviation “TJC”?
The Joint Commission
What is the meaning of the acronym “NABP”?
National Association of Boards of Pharmacy
What is the meaning of the acronym “NDA”?
New Drug Application
What is the meaning of the abbreviation “NF”?
National Formulary
How many different types of drug recalls exist?
3 different types of drug recalls
Who may initiate drug recall?
FDA or the drug manufacturer
What type of drug recall results in permanent harm or death to a patient?
class I
What is the meaning of the acronym “INDA”?
Investigational New Drug Application
Which organization establishes the standards for medications?
USP
What is the meaning of CSAR?
Controlled Substance Administration Record
Which reference book contains the USP and NF drug standards and dispensing requirements?
Drug Topics Orange Book
What is the acronym for an automatic stop order?
ASO
Which reference book is included in USP DI, volume III, and contains the FDA’s approved drug products?
Drug Topics Orange Book
What is the purpose of the DEA?
Enforcing the Controlled Substance Act of 1970
Which pharmacy text provides information regarding the entire practice of pharmacy (abbreviations, math, settings, equipment, how to compound various dosage forms, etc)?
Remington: The Science and Practice of Pharmacy
Which pharmacy text contains monographs about pharmaceuticals?
Drug Facts and Comparisons
What is the PDR made up of?
The Physician’s Desk Reference is a compilation of product inserts by the manufacturers to provide information to physicians.
What does the USP DI volume 1 provide information on?
It provides information on both labeled and unlabeled uses of medications and storage requirements
Who can issue a drug call?
The FDA or the manufacturer of the medication
What does USP DI volume 2 provide information on?
it provides information to assist the pharmacist in counseling patients
What does Drug Facts and Comparisons provide?
- Info on 4 types of drugs
- Plus 3 other things
Info on brand, generic, orphan, and investigation medications.
Drug monographs, drug identifications, and dosage calculations.
What does USP DI volume 3 provide information on?
it contains state and federal requirements of medications
When does a “code blue” occur?
When a patient is experiencing a life-threatening situation, such as a heart attack or when breathing has stopped
Which reference book is a compilation of package inserts?
Physicians’ Desk Reference
*contains info from the package inserts of more than 4000 prescription drugs
Which organization establishes the standards of care for hospitals and long-term care facilities?
TJC
Who does TJC accredit?
hospitals, long-term care facilities, home health care suppliers, and home infusion pharmacies
What type of drug recall occurs when a drug is not likely to cause a temporary adverse health consequence?
Class 3 recall
What type of drug recall occurs when a drug may cause temporary or medically reversible adverse health consequences?
Class 2 recall
What type of drug recall occurs when there is reasonable probability that use of the product will cause or lead to serious adverse health events or death?
Class 1 recall
Which rating indicates that a drug is contraindicated in pregnancy?
X
Which pharmacy organization was founded by pharmacy technicians, run by pharmacy technicians, and promotes the profession of pharmacy technicians?
NPTA (National Pharmacy Technician’s Association)
What does AAPT stand for?
American Association of Pharmacy Technicians
What does APHA stand for?
American Pharmaceutical Association
What does ASHP stand for?
American Society of Healthcare Pharmacists
What is the purpose of postmarketing monitoring of new drugs?
removal of unsafe drugs
What organization represents all 50 boards of pharmacy?
NABP (National Association of Boards of Pharmacy)
Which reference book is the official compendium of pharmaceutical products in the United States?
USP-NF (United States Pharmacopoeia–National Formulary)
What does USP-NF stand for?
United States Pharmacopeia - National Formulary
What phase for new OTC drugs occurs when a final review is done on the ingredients of the agent in question and the public is able to give feedback?
Phase 2
What phase for new OTC drugs occurs when advisers evaluate the agent in question as to whether it is safe and effective when taken by the consumer or patient?
Phase 1
What phase for new OTC drugs occurs when all the final evidence is presented and all aspects of the agent exhausted, and the final monograph is published?
Phase 3
What is the sensitivity of a class A balance?
6mg
According to the USP, how long can a low-risk compounded product be refrigerated?
14 days
According to the USP, how long can a low-risk compounded product be frozen?
45 days
According to the USP, how long can a low-risk compounded product be stored at room temperature?
48 hours
Which agency supervises the development, testing, purity, safety, and effectiveness of both prescription and OTC medications?
FDA
Which organization has regulations involving nuclear pharmacy?
OSHA
Which organization established the guidelines for medical records?
Centers for Medicare and Medicaid Services (CMS)
What type of container protects contents from contamination by liquids, solids, or vapors during normal shipping, handling, storage, and distribution?
Tight container
What term can be described as “the rules of a facility or institution?”
policy
What is protocol concerned with?
appropriate behavior
What are procedures involved with?
processes
What are standards?
expectations
