IV Add Mixtures Compounding Training

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Questions and Answers

What does turbidity in a compounded product indicate?

The product requires further monitoring.

The compounding procedure was followed correctly.

The product is sterile.

There has been viable contamination introduced. (correct)

Which of the following is NOT a primary engineering control in IV pharmacy?

Refrigerated storage unit (correct)

Laminar flow clean bench (LFCB)

Compounding aseptic isolator (CAI)

Laminar flow biological safety cabinet (BSC)

What is a critical aspect of quality assurance in pharmacy compounding?

Limiting the number of products compounded.

Using disposable materials only.

Sealing products in airtight containers.

Continuous monitoring and documentation. (correct)

What is the main function of the HEPA filter in engineering controls?

To provide sterile supply air. Signup and view all the answers

Why must compounding personnel follow unvarying procedures?

To mitigate the risk of contamination. Signup and view all the answers

What is a common defect that can occur with HEPA filters?

Physical damage from handling. Signup and view all the answers

How efficient is a properly functioning HEPA filter?

99.97% efficient at 0.3 microns. Signup and view all the answers

What is the purpose of secondary engineering controls?

To create a buffer zone between critical work areas. Signup and view all the answers

What happens if first air is not maintained properly?

Contamination risk increases. Signup and view all the answers

What denotes the importance of documentation in the quality assurance system?

It is the justification for product release. Signup and view all the answers

What could cause a failure in contamination control within a CAI?

Ignoring cleaning procedures. Signup and view all the answers

What does first air flow refer to?

The initial air released from the HEPA filter. Signup and view all the answers

Which device is specifically designed for use with hazardous drugs?

Compounding aseptic isolator (CAI) Signup and view all the answers

What is essential for maximizing the safety of all admixtures produced?

Selection of appropriate engineering controls. Signup and view all the answers

What is the main purpose of maintaining negative pressure in the exhaust duct of a BSC?

To prevent hazardous vapors from escaping Signup and view all the answers

What should be the sash operating height when using a BSC?

Eight inches Signup and view all the answers

How should hand movements be conducted when working within the BSC?

Slow and perpendicular motions Signup and view all the answers

What area must be kept clean to prevent contamination in a BSC?

The under tray area Signup and view all the answers

What is the most direct parenteral route for drug administration?

Intravenous route Signup and view all the answers

What happens if the sash of the BSC is fully closed during operation?

It causes overheating of the air handler Signup and view all the answers

What type of contamination poses a risk during intravenous drug administration?

All of the above Signup and view all the answers

Why is it essential to balance the airflow in a BSC?

To prevent backflow of contaminated air Signup and view all the answers

What is one significant reason for surface contamination found in pharmacy compounding areas using BSCs?

Inadequate training of personnel Signup and view all the answers

What are pyrogens primarily associated with?

Fever induction Signup and view all the answers

What does quality assurance (QA) focus on in a production setting?

Proof of consistent production of quality products Signup and view all the answers

Which practice should be followed when working with vials, needles, and syringes in a BSC?

Avoiding contamination of the protective air curtain Signup and view all the answers

What is the role of secondary engineering control in relation to a BSC?

To isolate the BSC from external contaminants Signup and view all the answers

What is the term for the process of ensuring that the production system can consistently produce acceptable products?

Validation Signup and view all the answers

Which of the following is a significant consequence of particulate matter introduced through IV administration?

Neurological complications Signup and view all the answers

What should practitioners involved in compounding hazardous materials undergo?

Rigorous training with validation exercises Signup and view all the answers

How does quality control differ from quality assurance in the context of injectable products?

Quality control assesses compliance before product release, QA focuses on production reliability. Signup and view all the answers

Why should no objects be placed on the air return grills of a BSC?

It obstructs airflow Signup and view all the answers

What must be demonstrated during a validation exercise for compounding IV products?

Proper use of engineering controls and aseptic techniques Signup and view all the answers

What is the air broom effect in a buffer zone?

Facilitates airflow to maintain cleanliness Signup and view all the answers

What is one of the main risks associated with intravascular infection from IV therapy?

Bacteremia Signup and view all the answers

What is the main purpose of USP 797?

To establish standards for compounding sterile preparations Signup and view all the answers

What must be logged during sanitizing operations in a BSC?

Sanitizing procedures on the hood cleaning log Signup and view all the answers

What is the ideal condition for the buffer zone in relation to air pressure?

It should be under positive pressure Signup and view all the answers

Which of the following is NOT mandated by the recent updates to USP 797?

Monthly sterilization of all equipment Signup and view all the answers

What does line clearance refer to in the context of drug production?

Removal of drug residues during sanitization Signup and view all the answers

Which personnel controls are essential to prevent contamination events during IV admixture?

Personnel training and proper workflow Signup and view all the answers

How many replicate demonstrations of competency in donning sterile gloves are required before compounding?

Three Signup and view all the answers

What do glove tip samples need to show in order to establish sterile glove competency?

Zero colony forming units Signup and view all the answers

What is a common reason for inconsistency in hospital pharmacy procedures across different satellite locations?

Autonomy in developing individual operating procedures Signup and view all the answers

What is a critical requirement concerning the environment in any facility compounding sterile preparations?

Periodic air quality testing Signup and view all the answers

What can be a result of allergic responses in the hospital environment?

Severe allergic reactions to latex Signup and view all the answers

Which route is highlighted as the natural path of absorption for drugs administered to patients?

Through the epithelium of various organs Signup and view all the answers

What method is used to validate that a compounding environment is adequate for sterile product preparation?

Simulation with microbiologic growth media Signup and view all the answers

What must be done with gloves after sampling the fingertips for microbial contamination?

They should be discarded and replaced. Signup and view all the answers

Which of the following personnel activities is directly prohibited by USP 797?

Making interpretations from the standard Signup and view all the answers

What initial action should pharmacy administration take to comply with USP 797?

Develop specific procedures and documentation Signup and view all the answers

What aspect of quality assurance does USP 797 emphasize for compounding?

Comprehensive documentation of procedures Signup and view all the answers

What is the intended outcome of the ongoing microbial monitoring process mandated by USP 797?

To maintain a near sterile environment Signup and view all the answers

Which is NOT a critical factor when selecting compounding personnel?

Previous awards in pharmacy practice Signup and view all the answers

What does ongoing microbial monitoring of glove tips and work surfaces help determine?

Frequency of disinfection procedures Signup and view all the answers

What does the compounding of sterile drugs aim to achieve?

Preparation without compromising quality Signup and view all the answers

What is the primary function of a HEPA filter in a laminar flow clean bench (LFCB)?

To supply clean air to the critical sites Signup and view all the answers

What effect can human movement have on the airflow in a laminar flow clean bench?

It can create backwash contamination Signup and view all the answers

Which of the following is a critical site in a laminar flow clean bench?

Open ampules Signup and view all the answers

What is the direction of airflow in a vertical flow clean bench?

From above to below Signup and view all the answers

What type of contamination can occur if critical sites are placed downstream from another object?

Downstream contamination Signup and view all the answers

What happens to the airflow in the front six inches of a laminar flow clean bench?

It can be contaminated due to backwash contamination Signup and view all the answers

How does cross stream contamination typically occur in a laminar flow clean bench?

By close placement of items and rapid hand movements Signup and view all the answers

What is the primary purpose of a biological safety cabinet (BSC)?

To protect both the user and the environment Signup and view all the answers

What happens in a type A biological safety cabinet regarding airflow?

70% of air is recirculated with no external exhaust Signup and view all the answers

What is a common psychological misconception that users may have about the clean bench environment?

The presence of the hood guarantees sterility Signup and view all the answers

Why is it critical to manage the air flow around critical sites?

To avoid airborne contamination of the product Signup and view all the answers

What is the primary air movement in a laminar flow clean bench?

Horizontal air movement only Signup and view all the answers

What happens if an object is placed against one of the side walls of a clean bench?

It increases the zone of confusion to six object diameters Signup and view all the answers

What is the primary purpose of using barrier controls in a compounding environment?

To prevent the spread of contaminants to critical areas Signup and view all the answers

Why should reusable cleaning equipment be dedicated solely for cleanroom use?

To ensure they are used in a hygienic manner Signup and view all the answers

What is the preferred type of gown for compounding hazardous substances?

Disposable gowns Signup and view all the answers

What is a common misconception about hand-washing related to microbial contamination?

It is sufficient for aseptic technique Signup and view all the answers

What is the primary function of shoe covers in a cleanroom setting?

To isolate shoe surfaces from outside contaminants Signup and view all the answers

What should be done with masks after use in a compounding area?

Disposed of immediately to avoid contamination Signup and view all the answers

What does resident flora refer to in the context of skin microbial contamination?

Flora that resides deep within skin layers Signup and view all the answers

Which feature is important for gloves used in compounding hazardous materials?

They need to fit properly for dexterity Signup and view all the answers

What is a major risk associated with not wearing gloves during compounding?

Higher contamination from microbial fallout Signup and view all the answers

Which of the following is true about hair covers in a cleanroom?

They must contain all hair with elastic fits Signup and view all the answers

Why is it crucial for the mask to have a proper fit during compounding?

To provide a snug barrier against respiratory droplets Signup and view all the answers

What must the gown used during compounding hazardous materials ensure?

It minimizes shedding of contaminants Signup and view all the answers

What is a flawed reason for not using gloves in compounding?

Preference for bare hands Signup and view all the answers

What is the primary contamination burden on the skin attributed to bare hands?

Resident flora Signup and view all the answers

What is the purpose of using sterile alcohol during glove sanitation?

To create a bacteriostatic barrier on the gloves and surfaces. Signup and view all the answers

What should be done before entering the buffer area?

Scrub hands and arms and put on gowns before glove application. Signup and view all the answers

Why is double gloving recommended when handling hazardous materials?

To provide a safety margin against glove leakage and tears. Signup and view all the answers

What should be done to gloves after loading compounding materials into the PE C?

Re-sanitize gloves with sterile alcohol. Signup and view all the answers

What is the primary reason for gowning and removing jewelry before compounding?

To prevent contamination of the buffer zone Signup and view all the answers

How should the outer gloves be removed to prevent contamination?

Use the fingers of the inner gloved hand to remove the outer ones. Signup and view all the answers

What is the recommended frequency for replacing the outer pair of gloves?

Every 15 to 20 minutes or when visibly contaminated. Signup and view all the answers

Which stage in aseptic manipulations occurs right after preparation?

Compounding Signup and view all the answers

What is the technique used for donning sterile gloves referred to?

Aseptic technique. Signup and view all the answers

What should be done if a biological safety cabinet's alarm sounds?

Verify the sash is at the correct operating height Signup and view all the answers

Why must gowns worn during compounding of cytotoxic agents be disposed of after use?

They may accumulate hazardous substances during use. Signup and view all the answers

What must be checked to ensure the proper operation of hood cleaning?

Cleaning logs and technician certification Signup and view all the answers

What is the correct method of removing a gown after compounding?

Grasp the outer surface and pull forward from the back. Signup and view all the answers

Why is 70% isopropyl alcohol not sufficient as a sole disinfectant?

It does not have a complete antimicrobial spectrum Signup and view all the answers

What is the recommended combination of alcohol for effective antimicrobial action?

70% alcohol and 30% water Signup and view all the answers

What type of hand scrub is recommended prior to donning sterile gloves?

Chlorhexidine surgical hand scrub. Signup and view all the answers

How should alcohol be applied to gloves during re-sanitization?

Apply sterile alcohol directly over the glove surfaces and rub hands together. Signup and view all the answers

What does the Magna hillock pressure gauge indicate?

The operational speed of the fans Signup and view all the answers

What must be verified prior to starting the compounding process?

All data logs are complete and accurate Signup and view all the answers

What happens to sterile gloves upon contact with non-sterile materials?

They become contaminated and should be sanitized. Signup and view all the answers

What could happen if gross contamination is present on materials transferred to the buffer zone?

Potential adverse reactions in patients Signup and view all the answers

What is the major lethal action of alcohol in decontaminating surfaces?

Antimicrobial action through plasmolysis. Signup and view all the answers

What is a common misconception regarding sterile alcohol as a disinfectant?

It can completely sterilize surfaces. Signup and view all the answers

Which of the following is a critical element of a pharmacy quality assurance program?

Engineering and facility control Signup and view all the answers

What is required for effective disinfection with alcohol?

Absorption by the microorganism and complete drying Signup and view all the answers

What must be done with all gowning used during hazardous substance compounding after removal?

They should be placed in a chemo waste container. Signup and view all the answers

What should be done with any items with gross contamination before entering the buffer zone?

Wipe them with low lint wipes moistened with 70% alcohol Signup and view all the answers

What is critical to ensure during the cleanup stage of aseptic manipulation?

Thoroughly clean and disinfect all work surfaces Signup and view all the answers

What is the recommended concentration of alcohol for effective disinfection?

70% Signup and view all the answers

What cleaning method should be used for the sides of a clean bench?

Vertical strokes from top to bottom Signup and view all the answers

When cleaning a clean bench, what should be avoided to prevent contamination?

Back-to-front wiping motions Signup and view all the answers

What type of gloves should be worn when compounding hazardous materials?

Three pairs of disposable gloves Signup and view all the answers

What must be done with a HEPA filter during cleaning?

It should never be cleaned Signup and view all the answers

Where should the waste container be placed during the cleaning process?

On a chemo mat at one side of the work surface Signup and view all the answers

What is the final step after cleaning the work surface in a BSC?

Place the outermost pair of gloves into the waste container Signup and view all the answers

Which of the following steps is crucial before handling hazardous materials?

Understanding emergency procedures Signup and view all the answers

How should spillage cleanup materials be treated?

As hazardous waste Signup and view all the answers

When cleaning the back wall of a clean bench, which direction should be used?

From top to bottom Signup and view all the answers

What should be done with the protective screen of the LFC B if it is designed to be removed?

Remove, clean, and carefully replace it Signup and view all the answers

How should the air flow in the clean bench be managed during cleaning?

Keep the hood running continuously Signup and view all the answers

Which material should not be used to clean the interior surfaces of the clean bench?

Inflammable materials Signup and view all the answers

What is essential to ensure while arranging working materials near the HEPA filter?

Working materials should be arranged parallel and near the filter. Signup and view all the answers

What should be done if the vacuum is not present in an evacuated container?

Discard the container. Signup and view all the answers

Which action is inappropriate during the preparation of hazardous materials?

Moving hands in and out of the hood frequently. Signup and view all the answers

What is the preferred syringe fill level when compounding hazardous materials?

Three-quarters full at most. Signup and view all the answers

How should flip-off caps be handled during the compounding process?

They should be placed near the side of the hood on a tray. Signup and view all the answers

What is a key factor in risk evaluation during the compounding procedure?

Minimizing exposure time of critical sites. Signup and view all the answers

What type of filters should be used with syringes for compounding hazardous drugs?

Hydrophobic filters. Signup and view all the answers

Which of the following statements about needle gauges is true?

Smaller diameter needles are preferred for creating punctures. Signup and view all the answers

What should be done with critical sites before commencing compounding operations?

Each site must be disinfected with 70% IPA. Signup and view all the answers

What is a common method for validating pharmacy operations?

Performing both technique validation and process validation. Signup and view all the answers

When should wrappers be removed during the compounding process?

After ensuring sterility requirements are met. Signup and view all the answers

What is the best practice regarding the arrangement of materials in a biological safety cabinet?

A checkerboard pattern can be used, taking care not to block airflow. Signup and view all the answers

What is the primary concern when using a syringe to draw up medications for compounding?

Avoiding touch contamination of the exposed hub and needle. Signup and view all the answers

What is the correct amount of solution needed to achieve 8 milliequivalents using magnesium sulfate with a concentration of 4.06 milliequivalents per milliliter?

3.94 milliliters Signup and view all the answers

Which conversion factor is necessary to relate milliequivalents to milligrams in the problem discussed?

Both A and C Signup and view all the answers

What fundamental understanding is highlighted as crucial for accurate calculations in the context of the discussed problem?

Understanding equivalent weights and conversions Signup and view all the answers

What was the initial condition specified for the required solution in relation to its concentration?

50% solution Signup and view all the answers

In solving the equation presented, what mistake is suggested to have been made based on the initial understanding?

Neglecting conversion factors Signup and view all the answers

What is essential for ensuring effective mixing of additives within the IV bag?

Mixing thoroughly after each addition. Signup and view all the answers

Why must a tuberculin syringe's needle be changed before drawing up a dose?

The new needle may hold more Delevan, impacting dosage accuracy. Signup and view all the answers

What risk is associated with injecting additives into a bag with a belly port?

Higher chance of needle puncture through the bag. Signup and view all the answers

What should be done with unused drugs and components in the compounding area after completion of activities?

Remove them to ensure no residues remain. Signup and view all the answers

What orientation is recommended for bottles and bags during preparation?

With the additive port facing right. Signup and view all the answers

What might happen if caps left open in the hood are used?

They may introduce germs into the sterile environment. Signup and view all the answers

What must be ensured when attaching an intravenous administration set?

It must be done before adding any drugs. Signup and view all the answers

What is a critical action after each addition of additives to ensure safety and accuracy?

Mixing thoroughly to avoid concentrated interaction. Signup and view all the answers

Which of the following is critical when preparing syringes for dispensing directly to floors?

Replacing the needle with a cap to maintain sterility. Signup and view all the answers

What must be visually checked before presenting final containers to the pharmacist?

For particulates against white and black backgrounds. Signup and view all the answers

Which procedure is recommended to assure consistency and avoid errors in compounding?

Staging no more than four identical orders at one time. Signup and view all the answers

What type of caps is discouraged for use with hazardous materials?

Push-on caps. Signup and view all the answers

What should be done if a dispensing pin is not suitable for very small vials?

Set the assembly aside and use a syringe instead Signup and view all the answers

Which action should be avoided to prevent contamination when using a dispensing pin?

Allowing the plunger to retract during dispensing Signup and view all the answers

What should be verified before starting the compounding process with an automated compounder?

The expiration date of the source container Signup and view all the answers

Why is calibration important when using an automated compounder?

To maintain accuracy in volume transfer Signup and view all the answers

How should an operator maintain first air flow when changing source bags?

Keep all spike covers firmly in place Signup and view all the answers

What is a critical step when using a repeating syringe to avoid cross-contamination?

Changing the needle between each use Signup and view all the answers

What must be done with the final container after compounding with an automated device?

It should not be disturbed in any way Signup and view all the answers

What vital aspect should a pharmacist verify during the compounding process?

The volume of the source solution Signup and view all the answers

What action should be taken to ensure the correct solution is connected to an automated compounder?

Check the labeling of all source bags before use Signup and view all the answers

What practice is essential when using needles during the compounding process?

Using a new needle for each drug transfer Signup and view all the answers

What must be done with vials and dispensing pen assemblies after use?

They should be capped and disposed of intact Signup and view all the answers

What procedure is important to ensure the accuracy of compounding?

Calibrating the automated compounder regularly Signup and view all the answers

When preparing a solution in a sterile environment, how should fingers be positioned when injecting additives?

Fingers should be kept away from the first air flow Signup and view all the answers

What type of needle should always be used when dispensing with a repeating syringe?

A vented needle or adapter Signup and view all the answers

What should be done with materials that have been used in compounding hazardous substances?

They must be disposed of as contaminated waste. Signup and view all the answers

Which of the following calculations is integral for IV admixture compounding?

Ratios and percentage calculations Signup and view all the answers

When performing calculations for pharmacy compounding, which principle should be adhered to?

Verify all calculations independently. Signup and view all the answers

What is the first step in converting ounces to grams using the information provided?

Find the conversion factor from a chart. Signup and view all the answers

How should the final answer in a calculation relate to significant digits?

It must adhere to the least number of significant digits in the calculation. Signup and view all the answers

Which of the following best describes a good aseptic technique in pharmacy compounding?

It is like a well-choreographed dance with planned movements. Signup and view all the answers

What mathematical approach is typically used to isolate an unknown in a ratio calculation?

Multiplying both sides by the known value. Signup and view all the answers

Which of the following types of calculations is essential for determining drug concentration?

Percentage calculations Signup and view all the answers

What action should a pharmacist take if the calculated dosage does not match the expected results?

Recheck calculations and verify inputs. Signup and view all the answers

What is the correct way to express 5 percent as a fraction?

5/100 Signup and view all the answers

In order to avoid unsafe mixtures during compounding, which factor is critical to control?

Introducing correct amounts of the right drugs. Signup and view all the answers

What should be done if a product is discovered to be contaminated?

It should be disposed of immediately as waste. Signup and view all the answers

What factor should be considered when writing new compounding procedures?

All new procedures should be written down. Signup and view all the answers

What does the process of converting a percentage back to a decimal fraction involve?

Dividing by 100 and removing the percent sign Signup and view all the answers

In a 20% zinc oxide ointment, how many grams of zinc oxide are present in 120 grams of the mixture?

24 grams Signup and view all the answers

What is the correct method for finding the total volume of a solution when the active ingredient and its concentration are known?

Multiply the active ingredient by 100 and divide by the concentration Signup and view all the answers

When rounding the total volume from a calculation that yields a decimal, what should you consider?

The last decimal place to determine if you should round up or down Signup and view all the answers

For a 70% alcohol-water solution with 55 milliliters of pure alcohol, what is the total volume of the solution?

78 milliliters Signup and view all the answers

What is the fundamental percentage equation for calculating percent strength?

Percent strength = amount of active ingredient / total amount of preparation x 100% Signup and view all the answers

When administering a solution with a flow rate of 70 milliliters per hour, how many hours will a 1000 milliliters solution run?

14 hours Signup and view all the answers

How do you convert milliliters per hour to milliliters per minute?

Divide by 60 Signup and view all the answers

What is the drip rate for a standard administration set in drops per minute if 1.111 milliliters per minute is the flow rate?

10 drops per minute Signup and view all the answers

What is the concentration in milliequivalents of magnesium sulfate in a 50% solution for an 8 milliequivalent delivery requirement?

16 milliliters Signup and view all the answers

Which method is used to calculate drug administration rates?

Total volume to be infused divided by infusion time Signup and view all the answers

Which of the following is true regarding significant digits in calculations?

Decimal places should influence the accuracy of final answers Signup and view all the answers

In the percentage weight in weight calculation, how is the concentration expressed?

Parts by weight of drug in parts by weight of mixture Signup and view all the answers

When calculating dosage and dilution, what must be ensured about the active ingredient and total amount?

They must be in the same unit or denomination Signup and view all the answers

What is the main risk associated with using an ampule during compounding procedures?

High contamination risk from airborne particles Signup and view all the answers

Which procedure is crucial to minimize contamination when using an ampule?

Disinfecting the neck of the ampule with an alcohol swab Signup and view all the answers

What should be done to the syringe after withdrawing the contents from the ampule?

Change it to a filter needle before making dosage adjustments Signup and view all the answers

What is the primary reason for using a hydrophobic filter when working with drugs and dispensing pins?

To prevent drug contamination in the environment Signup and view all the answers

Which of the following describes a step to help prevent touch contamination when handling ampules?

Wrapping the neck with a sterile gauze pad Signup and view all the answers

What is the proper technique for drawing up fluid from an ampule?

Keep the needle just above the fluid level while withdrawing Signup and view all the answers

Why is it important to maintain first air flow over the vial septum during compounding?

To prevent contamination of the sterile environment Signup and view all the answers

What is a critical action to take when preparing an ampule for use?

Thoroughly clean the neck of the ampule before use Signup and view all the answers

What should be performed after using a dispensing pin?

Dispose of it in the biohazard waste container Signup and view all the answers

What could result from not properly cleaning the neck of an ampule?

Greater risk of particulate contamination Signup and view all the answers

What is the role of the filter needle after drawing up contents from an ampule?

To filter out any particles or glass fragments Signup and view all the answers

What should be avoided when drawing up from an ampule to prevent contamination?

Allowing bubbles to form in the syringe Signup and view all the answers

What is advised to do if drug remains in the neck of the ampule after opening?

Reinsert the needle to extract remaining liquid Signup and view all the answers

Which factor contributes primarily to contamination risks when using dispensing pins?

Additional assembly manipulations involved Signup and view all the answers

What should be done to avoid touch contamination during the preparation of a syringe?

Ensure first air flows over both the syringe and vial. Signup and view all the answers

What does the seesaw technique involve during fluid withdrawal from a vial?

Alternating between pulling back on the plunger and allowing air into the vial. Signup and view all the answers

What should be verified by the pharmacist before injecting a drug into the final container?

The plunger position and vial label against the order. Signup and view all the answers

Which action is essential when drawing a liquid from a vial?

Positioning the needle bevel perpendicular to the septum. Signup and view all the answers

How should the vial and syringe assembly be held in a horizontal flow hood?

Completely inverted and held vertically. Signup and view all the answers

Which risk factor is associated with airborne contamination during compounding?

Disruption of first air flow over critical sites. Signup and view all the answers

What should be done with the cap of the needle before inserting it into the vial?

Removed without touching the exposed tip. Signup and view all the answers

What is a necessary step before reconstituting a powder in a vial?

Ensuring the vial septum is disinfected and alcohol is dry. Signup and view all the answers

What technique can be employed to hold a vial securely for manipulation during compounding?

Using a V grip with fingers. Signup and view all the answers

What should be done if air resistance is encountered during fluid withdrawal?

Release the plunger to allow air to enter the vial. Signup and view all the answers

What should be included on an ID label for multiple-use vials?

Date of opening, expiration date, and operator initials. Signup and view all the answers

Why is it important not to bend or distort the needle during the withdrawal process?

To maintain sterility by preventing needle damage. Signup and view all the answers

What does an incorrect dosing during reconstitution suggest?

The drug may not be fully dissolved. Signup and view all the answers

What is the primary goal of using first air during compounding?

To prevent contamination at critical sites. Signup and view all the answers

Study Notes

IV

Add Mixtures Compounding Overview

Training Program Structure: The program consists of five critical components: quality assurance, engineering controls, laminar airflow theory, barrier controls, aseptic manipulations, and pharmaceutical calculations. Quality assurance ensures that every step taken during the compounding process meets the established standards of preparation, thereby minimizing the risk of contamination and ensuring product potency. Engineering controls focus on the physical and environmental aspects of the compounding area, which includes ventilation systems, equipment, and workspace design, to optimize safety and efficiency. The laminar airflow theory is paramount as it explains the mechanics of airflow and how it can be utilized to protect sterile products from airborne contaminants. Barrier controls involve the implementation of protective measures that reduce the likelihood of contamination during compounding procedures. Aseptic manipulations are the techniques employed to maintain sterility throughout the preparation process, which is essential for preventing infections in patients. Lastly, pharmaceutical calculations are vital for ensuring accurate dosing and formula preparation, which directly impacts treatment efficacy. Mastery of these areas is not merely advantageous; it is a fundamental requirement for compliance with regulatory standards, ultimately ensuring elevated levels of patient safety and care quality.
Study Aids: An audiovisual study guide and the Vala Tech aseptic technique training manual support the training and must be studied before practical exercises. These aids are designed to enhance learning by providing visual context and detailed explanations of key concepts related to aseptic techniques, regulatory compliance, and best practices in compounding. Engaging with these materials allows participants to reinforce theoretical knowledge while preparing for hands-on applications that follow in the training program.

USP 797 Standards

Introduction: Chapter 797 of the United States Pharmacopeia (USP) was introduced in 2004 as a compulsory standard for compounding sterile preparations (CSPs). This chapter was established in response to significant public health concerns and incidents of contamination that posed serious risks to patients receiving sterile medications. The USP 797 standards outline the procedures and practices that must be followed to ensure the safety and effectiveness of compounded sterile products.
Updates: Revised in 2008, it includes requirements for facilities, personnel training, practices, and equipment. The revisions were made to address emerging evidence and technology in the field, highlighting the importance of continuing education and the implementation of best practices in compounding. These updates reflect growing awareness of contamination risks and the need for stringent controls in pharmacy settings.
Primary Goals: Aims to prevent patient harm from non-sterile compounds, which have been linked to severe patient morbidity and mortality. By establishing rigorous standards and protocols, Chapter 797 seeks to create a safe environment where pharmaceutical compounding can occur without compromising patient health. The ultimate goal is to ensure that every compounded preparation adheres to the highest levels of sterility and quality.
Legal Implications: Remains a standard of practice influencing pharmacy legislation in many states. Many regulatory bodies adopt these standards as part of state law, holding compounding pharmacies accountable for adherence. This fosters a culture of compliance and encourages pharmacies to invest in training, processes, and technologies that support safe compounding practices.

Compounding Requirements

Training & Competency: Enhanced training requirements include competency demonstrations for wearing sterile gloves and microbial monitoring of glove tips. These competency assessments ensure that personnel are well-trained in proper aseptic techniques, including how to minimize contamination risks during compounding procedures. Regular evaluations also help identify areas for improvement and encourage ongoing professional development among pharmacy staff.
Microbial Monitoring: Ongoing microbial monitoring of operatives' gloves and work environments is mandated, with specific testing for colony-forming units (CFUs). This proactive approach helps to detect potential contamination before it affects compounded preparations and ensures that safety protocols are being followed meticulously. By routinely sampling and analyzing microbial presence, pharmacies can establish benchmarks for cleanliness and make data-driven decisions to improve their processes.
Procedural Integrity: Significant focus on strict compliance with procedures and documentation for CSP pre-release checks. Rigorous checks and balances are established to guarantee that all compounded sterile preparations meet established safety and quality standards. Adherence to defined protocolos is critical in minimizing the potential for errors that could lead to adverse patient outcomes.

Quality Assurance Systems

Quality Control vs. Quality Assurance: Quality control ensures compliance through product testing, while quality assurance validates processes to consistently produce safe products. While quality control focuses on individual products after they have been produced, quality assurance encompasses the entire compounding process, emphasizing the importance of establishing robust systems that foster consistent quality and safety at every stage of preparation.
Validation Practices: Validation includes simulation with microbiologic growth media and ongoing monitoring of processes to maintain compliance. This multi-faceted approach involves testing the effectiveness of compounding practices under simulated conditions, as

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This quiz covers IV add mixtures compounding in modern hospital and home health care pharmacy. It includes five key areas: quality assurance, engineering controls, barrier controls, aseptic manipulations, and pharmaceutical calculations. Ideal for those undergoing Vala tech aseptic technique training.