PT217 Ch. 13 Sterile Compounding

What are the key characteristics an intravenous (IV) medication must have to be compatible with blood plasma?

pH value, osmotic pressure, and tonicity.

What does USP Chapter <797> cover?

The sterile compounding process.

What is the purpose of the master formulation record in sterile compounding?

It serves as a tested and approved recipe listing ingredients, procedures, and quality control for making a specific compounded sterile product (CSP).

What information is included in a compounding record?

Details of every compound made, including name, strength, dosage form, preparation date, technician initials, and total quantity compounded.

What is Total Parenteral Nutrition (TPN)?

A solution that supplies all of a patient's daily nutrition, often used for patients who cannot take food by mouth.

What are the components of a typical TPN solution?

Sterile water, dextrose, amino acids, electrolytes, vitamins, minerals, fatty acids, and sometimes insulin.

What is the difference between Total Parenteral Nutrition (TPN) and Peripheral Parenteral Nutrition (PPN)?

TPN provides all daily nutrition, while PPN provides only part of a patient's nutrition and is used for short-term (10-14 days).

What is the significance of Trissel's Stability of Compounded Formulations?

It is a reference for checking IV drug incompatibilities and provides stability and storage information.

What are the labeling requirements for a compounded sterile product (CSP)?

Order number, patient's name and ID, base solution and amount, additives and amounts, infusion rate, beyond-use date, storage requirements, and signatures.

What does the compounding process ensure for CSPs?

That the CSP is prepared correctly by following the master formulation record.

What are common calculations involved in sterile compounding?

Measurement conversions, solving for missing measurements, dimensional analysis, dilution calculations, and milliequivalent quantities.

What is a hazardous drug?

A drug that poses risks of exposure and requires specific handling and compounding controls.

What are primary engineering controls for compounding hazardous drugs according to USP Chapter <800>?

They include specific safety measures and equipment to minimize exposure to hazardous drugs.

What is the role of automated sterile compounding equipment?

To assist in the preparation of compounded sterile products while maintaining sterility.

What is the purpose of handling premade parenteral products?

To ensure safe and effective administration of IV medications using vial-and-bag systems and frozen solutions.

What is the importance of calculating infusion rates for IV solutions?

To ensure that patients receive the correct dosage of medication over a specified time.

What does BUD stand for in sterile compounding?

Beyond-Use Date, which indicates the time frame in which a compounded product should be used.

What are the general principles in sterile compounding?

To maintain sterility, ensure compatibility of ingredients, and follow safety protocols during preparation.

What is the significance of chemical compatibility in IV medications?

To prevent adverse reactions when different medications are mixed or administered together.

What is the function of a compounding record?

To document every aspect of the compounding process, ensuring traceability and accountability.

What is overfill in medication packaging?

The amount of solution added by manufacturers to compensate for water loss due to evaporation.

What is the common overfill rule used by many pharmacies?

A 10% overfill rule.

What must be done when adding a small volume medication to a solution?

Reconstitute the medication with diluent and administer the entire contents for a full dose.

How is volume withdrawal calculated when adding medication to a base solution?

Remove a volume from the base solution equal to the volume of the medication being added.

What is necessary when preparing intensely concentrated doses like chemotherapy?

Remove volume from the base solution equal to the medication volume plus any manufacturer overfill.

What is the purpose of using a new sterile container in medication compounding?

To ensure accurate medication amounts and maintain sterility.

What calculations are involved in determining the correct amount of IV bags needed for a 24-hour supply?

Calculations involve infusion rate, volume, tubing size, drip rate, and infusion duration.

What are single-dose vials (SDVs)?

Vials that do not contain a preservative and must be used within 6 hours.

What are multiple-dose vials (MDVs)?

Vials that contain a preservative and are stable for 28 days unless specified otherwise.

What technique should be used when withdrawing fluid from a vial?

Insert the needle at a 30- or 45-degree angle and then rotate to 90 degrees to prevent coring.

What is the process for reconstituting powdered medication in a vial?

Use a diluent and a vented needle to inject while venting the positive pressure within the vial.

What is the role of the pharmacist in the compounding process?

To complete the verification check of the CSP and ensure all components are correct.

What is priming in the context of IV administration?

The action of letting fluid run through the system to remove air bubbles before administration.

What are some hazards associated with hazardous drugs?

Carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity in low doses, and genotoxicity.

What do Safety Data Sheets provide for hazardous drugs?

Information on handling, exposure response, and spill procedures.

What are the categories for risk of exposure to hazardous drugs?

Needle stick injury, inhalation, ingestion, and direct skin contact.

What does USP <800> outline?

Requirements for the safe handling of hazardous drugs to protect patients, healthcare personnel, and the environment.