EXAM 3 Rules of the Board 1140-07 Flashcards
What must be submitted to the Board when a non-hospital facility compounds sterile products?
-Quantity of sterile products compounded and dispensed
-using board formatting
-need to specific documents and records ready if requested
-need to have specific documents and records ready if the board comes for inspection
Which standards need to be followed for sterile compounding according to the Board?
USP standards
Who needs to provide information to the Board when involved in sterile compounding?
Anyone involved in sterile compounding other than a hospital
-must submit quarterly (April, July, October, Jan 15th)
What are the requirements for the personnel involved in sterile compounding?
Policies and procedures: PIC is responsible
-Aseptic technique documentation for all pharmacists, techs, and interns involved in sterile compounding
->has to be done upon orientation (before they start) and annually
->anytime when improper technique is used -> documentation of training again
-PIC has to maintain a Quality assurance process
-need to be able to provide sterile products 24/7
What requirements are needed to work in sterile compounding?
for pharmacists, interns, techs:
-obtain training
-complete annual CE
-maintain documentation of the training on-site
What training information for sterile compounding needs to be recorded?
-Person being trained
-Date of training or evaluation
-Description of topics covered
-Signature of trainer/evaluator and PIC/designee
How often must the Policy and Procedure Manual be updated?
annually
What needs to be on the label of a sterile compounded product?
OUTPATIENT ???
-Patient name
-Prescriber name
-Pharmacy name, address, phone
-Directions for use
What needs to be on the label of a sterile compounded product?
***
ALL labels ???
-Healthcare entity name (in place of patient name)
-Pharmacist ID
-Intern/tech ID if applicable
-Name of drug added
-Amount of drug added
-Expiration time/BUD
-Date of compounding
-Appropriate auxiliary label(s)
What are the requirements for hazardous products?
-Minimal accepted hood type: Class II, Type A vertical flow biohazard cabinet
-hazardous cannot be kept with non-hazardous drugs in the pharmacy or storage area
-need an extra outer wrap for hazardous drugs to prevent leaking
What are the specific certifications that are required to work with hazardous drugs?
-need to be done annually for pharmacists, techs, and interns working with hazardous drugs
-Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs (Occupational) AND
-The American Society of Health-System Pharmacists (ASHP) technical assistance bulletin on handling cytotoxic and hazardous substances
What should be on the label of dispensed hazardous drugs?
***
a distinctive warning label and caution statement
What attire is required for working with hazardous products?
Gloves and gowning
What is required for the general compounding of sterile products?
-shall wear applicable outer garments
-shall use applicable respiratory precautions
Which Quality Assurance approach is performed by the board?
Gap analysis upon inspection -> reported to the board
-doesn’t say how often
