Quality assurance

Risk management for hazardous drug

- 2 gloves, -disposable gown - Use syringes and IV sets with Luer-lok fittings for prepare and administer -

FDA

- Oversees foods, drugs, medical devices, vaccines, blood biologics, cosmetics, radiation-emitting products, and tobacco, veterinary.

The main differences between QA and QC

- QA is for process and QC is for products - QA try to prevent error to occur - QC try to detect if any error occurred

FDA Adverse Event Reporting System (FAERS)

-database on adverse events and med error reports given to FDA -info used to ID possible safety concerns -manufacturers who receive adverse drug event report must submit info to FDA

ISMP reporting programs

1. ISMP -MERP: 2. ISMP -VERP both examine the cause of medication and vaccine errors and provide suggestions.

Which Org responsible for bioterrorism, drug preparedness and natural disaster response

FDA

Which Org responsible issues clinical trials and conduct postmarket surveillance program for newly approved drugs

FDA

which ORg approves and clears all medical devices, surgical implants, prosthetic adn in vitro diagnostics; issues alerts, notice, recall, postmarket surveillance for medical devices

FDA

which ORg approves veterinary drugs, receive report of adverse effects

FDA

which ORg oversees, issues recall and shortage of biologics ( a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins)

FDA

Which of the following has been identified by MEDMARX as the leading cause of medication errors?

MEDMARX has identified performance deficit as the largest cause of errors.

What form use to inform a drug manufacturer of errors caused by commercial packaging and labeling

MERF: Medication error report form

Organizations promoting Quality assurance

USP, FDA, TJC, ISMP, APhA (American Pharmacists association), American society of health system pharmacists Accrediting council of pharmacy education State board of pharmacy National association of boards of pharmacy Occupational safety and health administration

Assist the BOP - address standards for electronic prescribing, over describing controlled substances, pharmacy tech education, prescription monitor program

National association of board pharmacy

STAT

fill within 15mins

Quality control

focuses on identifying defect. QC ensures that the approaches, techniques, methods and processes are designed in the project are following correctly. Quality Control is a reactive process and is detection in nature.. It recognizes the defects. Quality Control has to complete after Quality Assurance.

Quality Assurance

focuses on preventing defect. Quality Assurance ensures that the approaches, techniques, methods and processes are designed for the projects are implemented correctly. Quality Assurance is a proactive process and is Prevention in nature. It recognizes flaws in the process. Quality Assurance has to complete before Quality Control.

What is the established (official) United States adopted name of a drug called?

generic

Control

is to test or verify actual results by comparing it with the defined standards.

VAERS (Vaccine Adverse Event Reporting System)

keeps track of all events associated with Adverse effects after administered vaccine. Administered by FDA

Physician order sheets POS

list of all orders of physician for a patient including both drug and nondrug orders

Pharmacy technician license

maintain by taking 20 hours of continuing education every 2 yrs with 1 hour being on topic of law

MAR

medication administration record: document medication administered to a patient.

Vaccine adverse reporting system VAERS administered by

national vaccine safety and surveillance administered by FDA

ASAP

need to process as soon as possible but not priority as STAT

color of sharp container

red

narcotic drug counting

twice and be verified by another tech or pharmacist

Accredits professional degree programs in pharmacy and provider of continuing education Establishes standard for pharmacy continuing education

ACPE: accrediting council of pharmacy education

ASHP Guidelines on quality assurance for pharmacy prepared products

3 levels 1. Drugs are stored at room temp and administered completely within 28 hours after prepared; products prepared by closed system aseptic transfer of nonpyrogenic, sterile products from license manufactures. 2. more than 28 hours at room temp

How many technicians can a pharmacist supervise at one time?

4

Laminar hood flow need to be certificated

6months

code for receiving a specific drug at a specified time each day.

A standing order calls for receiving a specific drug at a specified time each day.

Provide information resources for both pharmacist and pharmacy technicians

APhA

Develop the pharmacy technician intiniatives

American society of health system pharmacists

Provide continuing education through print media, e-learning, webniars, podcast and specialty certification

American society of health system pharmacists

accredits pharmacy technician training program

American society of health system pharmacists

Balance in pharmacy must be

Certificated by Department of Taxation every year Weights have to be calibrated annually

Evaluate radiation emitting products, medical imaging, and radiation safety

FDA

Issues labeling for tobacco

FDA

which ORg establishes time limits on the filling of medication order

Institutional of pharmacy and therapeutics (P&T)`

ISMP

Provides impartial, timely, and accurate medication safety information: - Community Pharmacy medication safety tools and resource - Guideline for preventing medication errors in pediatrics - Improving medication safety in Anticoagulant therapy - Patient controlled analgesia - Standard concentration of neonatal drug infusion - Error prone abbreviation lists - ISMP confused drug name list -ISMP list of high alert medications - ISMP list of high alert medication in community and ambulatory - ISMP list of products with Drug name suffixes - Tall men letter - Do not crush list - black box warning

The Joint Commission

Sets quality standards for accreditation of health care facilities - accredit for health care facilities: certification for special disease care.. - Established patient safety goals -

United States Pharmacopeia

Sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. - Publishes United States Pharmacopeia and National Formulary (USP-NF) contains standard for chemical and biology drug substance, excipients, medical divices... - Drug marketed in the US have to follow USP-NF - Established USP 795 and 797 - limit the adulterants and contaminants in dietary products - requirements for labeling of medications: wether they are multidose vial or unit dose container, IV admixture or compound Manufacturers of nutrient or dietary supplement may voluntarily choose to have their product approved by the United States Pharmacopeia. United States Pharmacopeia's drug standards are enforceable in the United States by the FDA.

Ensure the standard are met for the licensing of pharmacists, permits are issued for pharmacies and pharmacy technician meet specific standard Discipline pharmacies, pharmacists, pharmacy technicians

State board of pharmacy

Address healthcare-associated infection, infection control, and patient safety concerns, medication errors

TJC

Medwatch

The FDA safety information and adverse event reporting program report incidents related to serious AE for human medical products, biological drugs, medical device, special nutritional products, cosmetics, Is not used for vaccine report Provide safety alert for all information above

automated compounding and repackaging equipment must be calibrated

before each use