Pharmacy Quality Assurance Flashcards
What does the United States of Pharmacopeia (USP) do?
-They set standards for identity, strength, quantity and purity of medications, food ingredients and dietary supplement
Who published the USP-NF and what does it stand for? what is it’s purpose?
It stands for the United States of Pharmacopeia and National Formulary
- -this sets standards for compounding medication
- -Food Drug and Cosmetic Act made this a standard
What does USP <795> mean?
it is a code that establishes non-sterile compounding requirements
What does USP <797> mean?
it is a code that establishes sterile compounding requirements
Who establishes requirements for labeling medication?
United States of Pharmacopeia
Who addresses bio terrorism and national disasters during emergencies?
Food and Drug Administration
Who accredits and certifies health care organizations and programs in the United States?
The Joint Commission
What does ISMP stand for and what do they do?
It stands for Institute of Safe Medication Practices
–provides accurate and timely medication safety information
collect/ analyze reports of medication errors
–educate HCP and consumers
What does APhA stands for?
It stands for American Pharmacist Association
What does the APhA do?
provides informal resources and continuous education like certificate training
–advocates for practice of pharmacy
What does the American Society of Health System Pharmacist do?
accredits pharmacy technician programs
What does stand for ACPE and what do they do?
Accrediting Council of Pharmacy Education
–it accredits pharmacy degree programs and ensures advances and quality of pharmacy education
What does the State Board of Pharmacy do?
They ensure specific standards are met for the licencing of pharmacists as well as pharm techs
–they also discipline pharmacists and technicians for egregious conduct
What does NABP stand for and what do they do?
National Association of Board of Pharmacy
– assists SBOP in enforcing uniform standards for protection of public health
What does OSHA stand for and what do they do?
Occupational Safety and Health Administration
–ensure safe working conditions
What are the steps to applying a PPE (personal protective equipment)?
- hand hygiene
- gown
- mask
- goggles
- gloves
What are the steps to removing a PPE?
- gloves
- goggles
- gown
- mask
- hand hygiene
What is level one of quality assurance for pharmacy-prepared products?
Products stored at room temperature and administered within 28 hours
What is level two of quality assurance for pharmacy prepared products?
Products administered more than 28 hours after prep and stored at room temperature
What is level three of quality assurance for pharmacy prepared products?
Compounded from nonsterile components, containers or equipment
What does the Omnibus of Budget Recognition Act of 1990 (OBRA-90)?
it requires all pharmacists to perform a drug utilization evaluation (DUE) during the processing of prescriptions
What does the FDA Safety Info and Adverse Event Reporting Program do?
It provides online voluntary reporting form to report incidents
–NOT used to report vaccine events
What is FAERS and what does it stand for?
FDA Adverse Event Reporting
–its a database on adverse events and medical error reports
What is VAERS and what does it stand for?
Vaccine Adverse Event Reporting System
–info on events with adverse effects from vaccines
How does an FDA Product Recall occur?
- the pharmacy is notified by the FDA, drug manufacturer or wholesaler
- medical recalls will be found on FDA website
- pharmacist sees if it’s n stock, then contacts the patient
- recall medications returned to manufacturer for credits
What happens in a drug shortage?
- drug manufacturer is not required to provide info on drug shortage
- if drug shortage occurs, the FDA finds alternative sources for specific product
What controlled substance form used for?
it allows nursing staff to verify controlled substances at each charge shift
What is a MAR and what does it stand for?
medication administration record
-used to document medication given to patient
What is a Medication delivery record?
provides accountability for medication distribution between pharmacy and hospital or long-term care facility
What is a physician order sheet (POS)?
orders listed from physician to patient
What is the Resident Monitoring Form?
Document behavior of a patient and prescription factors
What must a pharmacy environment have?
- running hot and cold water
- mild detergent used to clean instrument
- 70% isopropynol used to clean counter tops
- fire extinguisher needs yearly certification
What equipment needs to be in a pharmacy?
- Pharmacy Balance require certification by department of taxation yearly
- pharmacy weights collaborated yearly
- counting trays cleaned with alcohol
- laminar flow hood need to be on for 30 minute before using it
- —-needs certification every 6 months
How do you deal with hazardous drugs?
- wear two pairs of powder-free chemotherapy gloves
- use syringes and IV sets with fittings when dealing with hazardous drugs
What is the best and preferred method to provide a prescription?
E-prescribing
How often should hypoallergenic gloves be changed?
hourly
Who develops the formulary?
Pharmacy and Therapeutics (P and T)
