Hazardous Drug Safety Procedures

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Questions and Answers

Which of the following situations does NOT require decontamination?

Before and after certification

When spills occur

During routine maintenance of equipment (correct)

Monthly under the work tray

What is the minimum personal protective equipment (PPE) required for personnel when dealing with hazardous drug contamination?

Single pair of latex gloves

Respiratory mask and safety goggles

Face shield and cloth gown

An impermeable disposable gown and two pairs of chemotherapy gloves (correct)

What does proper aseptic technique ensure during the compounding of sterile products?

Improved efficiency in drug compounding

Maintaining an ISO class 5 environment and preventing contamination (correct)

Reduction of waste materials produced during compounding

Complete elimination of all pathogens from the environment

Why might respiratory protection be necessary when cleaning under the work tray?

Containment airflows are compromised when opening cabinets Signup and view all the answers

Which of the following is NOT part of a compounding facility's standard operating procedures regarding cleaning?

Use of expired cleaning agents Signup and view all the answers

What is a requirement for gowns worn in HD areas?

Gowns must close in the back and have long sleeves. Signup and view all the answers

When should gowns be changed if the manufacturer's information is unavailable?

Every 2-3 hours. Signup and view all the answers

What should be worn when there is a risk of spills or splashes of HDs?

Eye and face protection. Signup and view all the answers

What type of respirator is usually sufficient for activities requiring protection from HD airborne particles?

N95 respirator. Signup and view all the answers

Which statement is true regarding the use of shoe covers in HD areas?

A second pair must be donned before entering the hazardous buffer area. Signup and view all the answers

What type of eye protection is inadequate against splashes?

Safety glasses with side shields. Signup and view all the answers

What is the role of sterile sleeve covers when compounding category 3 CSPs?

They provide protection from HD residue. Signup and view all the answers

When is a full-facepiece respirator necessary?

When attending to an HD spill larger than manageable with a spill kit. Signup and view all the answers

What is one of the minimum documentation requirements for evaluating a person?

Name of person evaluated Signup and view all the answers

What temperature range should the media device be incubated at for the first 48 hours?

30 to 35 degrees Celsius Signup and view all the answers

Which substance is typically NOT used in sampling media for gloved fingertip sampling?

Isopropyl alcohol Signup and view all the answers

What is the purpose of cleaning surfaces in classified areas?

To remove visible solids and potential sources of contamination Signup and view all the answers

How should media devices be labeled during the gloved fingertip sampling procedure?

With the personnel identifier, right or left hand, and date and time Signup and view all the answers

What is NOT a result expected from a sporicidal disinfectant on a surface?

Creation of a protective barrier Signup and view all the answers

During gloved fingertip sampling, what should be done with the agar to prevent contamination?

Invert the media devices Signup and view all the answers

What is a key role of disinfectants in the cleaning process?

They destroy fungi, viruses, and bacteria on surfaces Signup and view all the answers

How often should the interior surfaces of the PEC be disinfected on days when compounding occurs?

Daily Signup and view all the answers

What is the frequency of applying a sporicidal agent to Category 3 CSPs inside the PEC?

Weekly Signup and view all the answers

When should cleaning occur for the work surface of the removable tray of the PEC?

Daily on compounding days Signup and view all the answers

Which areas should be cleaned monthly underneath the work surface of the removable tray of the PEC?

All surfaces and areas Signup and view all the answers

How frequently should pass-through chambers be disinfected on compounding days?

Daily Signup and view all the answers

What must be done to any residue left by a germicidal agent after cleaning?

It should be thoroughly removed Signup and view all the answers

What is the cleaning frequency required for all surfaces and areas outside the PEC?

Not required Signup and view all the answers

What should be done on days when surface contamination is suspected in the PEC?

Clean and disinfect Signup and view all the answers

Which statement is true regarding the use of sporicidal agents?

They are applied weekly for Category 3 CSPs Signup and view all the answers

What cleaning schedule is indicated for floors in the PEC?

Not specified Signup and view all the answers

What is the purpose of the silicone coating on a needle shaft?

To enable smooth penetration of latex vial tops Signup and view all the answers

Which gauge needles are commonly used in pharmacies?

16 and 18 gauge Signup and view all the answers

What should be done to ensure safety when recapping a needle?

Scoop method should be utilized Signup and view all the answers

What characteristic differentiates vented needles from standard needles?

They have built-in vents to release pressure Signup and view all the answers

What is the maximum volume that may remain in the hub of a needle?

0.3 mL Signup and view all the answers

Why should needles never be swabbed with alcohol?

It can interfere with penetration of the vial Signup and view all the answers

How should needles be handled to prevent contamination?

Manipulate by their overwrap and protective covers only Signup and view all the answers

What is termed the 'bevel heel' of a needle?

The base of the needle where it connects to the hub Signup and view all the answers

Study Notes

Gown Requirements

Gowns must close in the back, have long sleeves, and closed cuffs made of elastic or knit.
No seams or closures that could allow hazardous drugs (HDs) to pass through are permitted.
Gowns must be changed based on the manufacturer's information for permeation of the gown or every 2-3 hours when the information is unavailable.
Gowns must be changed immediately following a spill or splash.
Gowns worn in HD areas must not be worn into other areas to prevent the spreading of HD contamination.

Head, Hair and Shoe Covers

Head, hair, and shoe covers protect the compounder from contact with HD residue.
A second pair of shoe covers must be donned before entering the hazardous buffer area and must be doffed when exiting this area.
Shoe covers worn in hazardous areas must not be worn into other areas to prevent the spreading of HD contamination.

Sterile Sleeve Covers

Sleeve covers protect the compounder from contact with HD residue.
Sterile sleeve covers must be used with a Restricted Access Barrier System (RABS) when compounding category 3 Compounded Sterile Preparations (CSPs).
Disposable sleeves may be used to protect areas of the arm that may come into contact with HDs.
Coated sleeve covers provide better protection than uncoated materials.

Eye and Face Protection

Eye and face protection must be worn when there is a risk of spills or splashes of HDs.
Goggles must be worn when eye protection is needed. Eyeglasses or safety glasses with side shields do not adequately protect the eyes from splashes.
Face shields alone do not provide full eye and face protection.
Face shields in combination with goggles provide the best level of protection to the face and eyes.
Surgical masks should not be used when protection from drug exposure is necessary as they do not provide respiratory protection.
For most activities requiring protection from HD airborne particles, a fit-tested NIOSH-certified N95 or more protective respirator is sufficient.
N95 respirators do not protect against gases or vapors and provide little protection against direct liquid splashes.
Some circumstances necessitate the use of a full-facepiece, chemical cartridge-type respirator or a powered air-purifying respirator (PAPR). These include attending to an HD spill larger than what can be handled with a spill kit.

Minimum Documentation Requirements for HD Stability Testing

Name of person evaluated
Evaluation date and time
Media and components including manufacturer
Expiration date
Lot number
Starting temperature for each interval of incubation
Dates of incubation
Results and identification of the observer and personnel reading and documenting the results

Gloved Fingertip and Thumb Sampling Procedure

Use one sampling media device per hand, containing general microbial growth agar (e.g., trypticase soy agar [TSA]) supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth.
Label each media device with a personnel identifier, right or left hand, and the date and time of sampling.
Using a separate media device for each hand, collect samples from all gloved fingertips and thumbs from both hands by rolling fingertips and thumbs over the agar surface.
Incubate the media device at 30 degrees Celsius to 35 degrees Celcius for no less than 48 hours and then 20 degrees Celcius to 25 degrees Celcius for no less than 5 additional days. Samples must be incubated in an incubator. Handle and store media devices to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the CFU readings (e.g., inverted plates).
Record the number of colony-forming units (cfu) per hand (left hand, right hand).
Determine whether the cfu action level is exceeded by counting the total number of cfu from both hands.

Cleaning and Disinfecting

Cleaning removes visible solids from the surface such as dirt, debris, residual drugs and chemicals, and microbes. These agents generally contain a surfactant.
Disinfectants destroy fungi, viruses, and bacteria present on surfaces using a chemical or physical agent.
Sporicidal disinfectants destroy bacterial and fungal spores on a surface when used at a sufficient concentration for a minimum of the specified contact time. These are also expected to kill all vegetative microorganisms.

Cleaning and Disinfecting Frequency Table

Location	Cleaning	Disinfecting	Sporicidal Agent Applied
PEC - all interior surfaces	Daily on days when compounding occurs and when surface contamination is known or suspected	Daily on days when compounding occurs and when surface contamination is known or suspected	Category 1 and 2 CSPs - Monthly. Category 3 CSPs - Weekly
Equipment inside the PEC	Daily on days when compounding occurs and when surface contamination is known or suspected	Daily on days when compounding occurs and when surface contamination is known or suspected
Pass-through chambers	Daily on days when compounding occurs	Daily on days when compounding occurs
Work surfaces outside the PEC	Daily on days when compounding occurs and when surface contamination is known or suspected	Daily on days when compounding occurs and when surface contamination is known or suspected
Floors	Daily on days when compounding occurs and when surface contamination is known or suspected	Daily on days when compounding occurs and when surface contamination is known or suspected
The work surface of the removable tray of the PEC if applicable	Daily on days when compounding occurs	Daily on days when compounding occurs	Monthly
All surfaces and areas underneath the work surface of the removable tray of the PEC if applicable	Monthly	Monthly
Walls, doors and door frames	Monthly	Monthly
Ceilings	Monthly	Monthly
Storage shelving and bins	Monthly	Monthly
Equipment outside the PEC	Monthly	Monthly

Cleaning using a germicidal agent will leave a residue on the surface that must be removed.
Decontamination is required between compounding of different drugs (work surface), at least daily, when spills occur, before and after certification, any time voluntary interruption occurs, the ventilation tool is moved, and monthly under the work tray.
Before accessing the area under the work tray the surfaces of the PEC should be decontaminated and cleaned. Respiratory protection may be required when cleaning and deactivating under the work tray as the containment airflows are compromised when opening the cabinets.
Each compounding facility must establish standard operating procedures on cleaning, deactivation, and decontamination procedures, agents utilized, dilution of agents, frequency of cleaning, and documentation of cleaning requirements.
All personnel must be trained in these procedures to protect themselves and the environment from contamination.
Appropriate PPE should be worn by personnel to protect them from HD contamination and the cleaning agent being utilized. This includes at a minimum an impermeable disposable gown and two pairs of chemotherapy gloves.

### Aseptic Technique

The term "aseptic" means free of living pathogenic organisms or materials.
Aseptic technique defines the technique necessary when preparing sterile products so that they remain sterile or free of living pathogenic organisms or materials.
Proper aseptic technique when preparing sterile products requires the use of the proper equipment to provide an ISO class 5 environment. The use of such a device does not ensure that products compounded within it remain sterile. The technique of the personnel using the hood has also impacts the quality of the final product.

Needle Anatomy

The length of a needle shaft is measured in inches and usually ranges from 3/8 to 3 ½ inches.
The gauges typically used in the pharmacy include 16 and 18 gauge.
The components of a simple needle are the shaft and the hub. The hub attaches the needle to the syringe and is often color-coded to correspond to a specific gauge.
The tip of the needle shaft is slanted to form a point. The slant is called the bevel, and the point is called the bevel tip. The opposite end of the slant is termed the bevel heel.
No part of the needle should be touched. Needles should be manipulated by their overwrap and protective covers (needle cap) only.
A needle shaft is usually metal and is lubricated with a sterile silicone coating so that latex vial tops can be penetrated smoothly and easily. For this reason, needles should never be swabbed with alcohol.
Inside a Laminar Airflow Hood, airflow to the needle shaft or hub opening should not be blocked.
Before using the needle, the compounding personnel should make sure the packaging and needle is intact and undamaged.

### Specialized Needles

Some needles are designed for special purposes and therefore have unique characteristics.
Needles designed for batch filling have built-in vents (vented needles) to avoid the need to release pressure that might form in the vial.
Needles with built-in filters are intended for use with products requiring filtering, such as drugs removed from a glass ampule.

### Needle Considerations

When dealing with small volumes, it is important to account for the volume of the solution left in the hub of the needle (up to 0.3mL).
To avoid any sharps related injuries, compounding personnel should avoid recapping of needles. Personnel may dispose of needles in a proper sharps container still attached to the syringes or a safety needle may be utilized that allows for a guard to flip up into place to cover the needle after use.
If it is necessary to recap a needle, a scoop method should be utilized. The needle cap should be left on the surface of the direct compounding area and the needle should be used to scoop up the cap. The personnel may then push on the cap to secure it into place. Use of these methods help to prevent personnel injuries and product contamination.

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Description

This quiz covers essential safety procedures for handling hazardous drugs, including gown requirements, head and shoe covers, and sterile sleeve covers. Understanding these guidelines is crucial to prevent contamination and ensure safety in hazardous areas.