Law final exam: USP Flashcards

Question

<797> Cleaning Schedule with 70% Isopropyl Alcohol after cleaning steps

Answer 1

Workbench Surface – Primary Engineering Control (PEC) – Start of each shift – Before each batch – At least every 30 minutes when compounding unless your compounded product takes longer than 30 minutes than immediately after completing the product – After spills – Surface contamination is suspected

Answer 2

Buffer and Ante Rooms – Daily ■ Trash ■ Floors ■ Counters – Not including the primary control workbench – Monthly ■ Ceilings ■ Walls ■ Storage Shelving – Shelving – all content must be removed and then cleaned *for high risk compounding facilities this may be done more frequently

Answer 3

Definition – Low-risk preparation for immediate administration, harm to the patient if the product is delayed ■ Product can be mixed outside of the Primary Engineering Control (PEC) system ■ Must meet the criteria below to fit this category: – Personnel are trained in USP 797 and demonstrate competency in aseptic processes – Final product contains no more than 3 ingredients – Administration within 4 hour – Must have a label added to the product

Answer 4

category 1 - environment - Storage conditions (e.g. controlled room, refrigerator) category 2 - Environment - Storage conditions (e.g. controlled room, refrigerator) - Compounding method - Sterility testing is being done - Starting compounding components (sterile vs nonsterile) category 3 - Environment - Storage conditions (e.g. controlled room, refrigerator) - Compounding method - Sterility testing is being done - Starting compounding components (sterile vs nonsterile) Factors that can help extend BUD (also under category 3) - Increase the use of sporicidal disinfectants - Increase in environmental monitoring - Stability determination data - Personnel training and qualifications

Answer 5

This should include: – Name, strength, and dosage form – All Ingredients and characteristics if applicable – Type and size of container closure system – Complete instructions including equipment, supplies, description of each step and any special precautions – Physical description of final product – Reference source to support the stability of the CSP – Beyond Use Date (BUD) and storage requirements – Other information as needed (e.g. sterilization method used) no need to memorize list just know that there is a master form. record, additional pieces to include for 797 and not 795 – Type and size of container closure system – Physical description of final product – Reference source to support the stability of the CSP

Answer 6

When product was made, by whom, and other trackable information ■ Should include: – Name, strength, and dosage form – Master formulary reference – Components ■ Name, quantity (weight or volume), strength or activity, source/manufacturer, lot number, expiration dates – Total quantity compounded – Identity of compounder and person completing the final check – Date made – Final yield (e.g. number of units, containers, etc.) – Control number or prescription number – Beyond Use Date (BUD) and storage requirements – Quality control information (e.g. visual inspection, filter integrity testing, pH testing, etc.) – Calculations made to determine quantities and/or concentrations

Answer 7

After compound complete label must include: – All active ingredients, amounts, strengths, concentrations – Total volume of compound – Beyond Use Date (BUD) – Dosage form – Storage information if other than controlled room temperature – Internal identification number (e.g. barcode, prescription, order, or lot number) Upon dispensing of the compound additional label must include: – Patient name and indentifiers – Route of administration – Administration instructions – Special handling or warnings if applicable Additional labeling requirements may be required based on your state laws or facility SOPs.

Answer 8

Genotoxicity – Potential to damage DNAcan lead to cancer ■ Organ toxicity – Potential to cause damage to an organ at low doses ■ Teratogenicity – Potential to fetal harm ■ Reproductive toxicity – Potential to cause damage to the reproductive organs ■ Carcinogenicity – Potential to cause cancer

Answer 9

HDs should be – Visibly inspected for damage – Separated from other medications – Unpackaged and immediately placed in a HD storage area – Appropriate personal protective equipment should be worn when opening and removing content from packages

Answer 10

HDs should be: – Assessed for risk ■ HD that require manipulation should be stored away from other drugs ■ HD that are single dose packaged and do not require manipulation can be stored with non-HDs – Stored in a way that prevents spills, leaks, or breakage if the container falls ■ They can not be stored on the floor. ■ Shelving with raised lips on the front are a good option

Answer 11

Persons compounding HD: – Should wear personal protective equipment (PPE) including a chemotherapy gown, two pairs of shoe covers, and two sets of chemotherapy gloves American Society for Testing and Materials (ASTM) – standards for chemotherapy designation If there is a risk of dust or debris a N95 mask is required If there is concern about the vaporization of medication a respirator is required – Negative pressure technique for IV compounding should be used or a closed system transfer device (CSTD) should be used to prevent contamination of HD - aseptic technique

Answer 12

HD Sterile Preparation: – In a negative pressure area to prevent the spread of hazardous materials – Ante Room Required to be ISO Class 7 – this to maintain the negative pressure environment to prevent the spread of HD particles HD Nonsterile Preparations: – Containment ventilated enclosure or biological safety cabinet need to be used to prevent the spread of HD ■ This is different than non-HD ■ Required to be ISO Class 5

Answer 13

All HD should be: – Labeled stating “Caution: Hazardous Drug” – All antineoplastics (chemotherapy agents) should be labeled with “Chemotherapy – Dispose of Properly” – IV ports can be sealed to provide a physical barrier and prevent leakage

Answer 14

Administrator should: – Wear proper PPE ■ All antineoplastics require two pairs of chemotherapy gloves – If an injectable this also requires a chemotherapy gown – Single pair of glove is acceptable if it is a intact tablet or capsule ■ Single pair of gloves should be worn for other types of HD

Answer 15

Yellow Disposal Bins – Trace HD – All PPE worn during compounding is considered contaminated ■ Inner gloves and inner shoe covers are not and can be discarded in the regular trash – Empty vials, syringes, IV bags, IV tubes ■ Black Disposal Bins – Bulk HD – Unused or partially empty vials, syringes, IV bags

Answer 16

Deactivation/Decontamination *2% sterile bleach or peroxide *Reduces toxicity and removes HD residue - break down the chemical structure Cleaning *Germicidal Detergent *Removes dirt and microbe contamination Disinfection *70% Sterile Isopropyl alcohol (IPA) *Inhibits or destroys microbes.

Answer 17

Prior to the start of the position and then at least annually (every 12 months) – Additional training should occur: ■ Prior to new protocols or processes going into effect ■ New equipment being used ■ A consent form for all workers should be obtained acknowledging the risks of handling HD.

Answer 18

Ampule - if you open it, use it immediately Inside ISO 5 PEC & Outside ISO 5 PEC - Immediate use only Single-dose vial Inside ISO 5 PEC: 12 hours Outside ISO 5 PEC: 0 seconds Pharmacy bulk package Inside ISO 5 PEC: 12 hours Outside ISO 5 PEC: 0 seconds Multi-dose vial - has antimicrobial agents Inside ISO 5 PEC: 28 days Outside ISO 5 PEC: 28 days Each medication should be checked with the package insert at the manufacturer's directions. Some medications may have a shorter timeframe. Multi-dose vials have preservatives in them allowing for an extended time.

Answer 19

water activity

Answer 20

Recipe to make the compound

Answer 21

Record of making the product

Law final exam: USP Flashcards

(46 cards)