infection control in pharmacy

7/30/2019 Infection Control in Pharmacy

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Infection Control in- Pharmacy

- TPN &IV Preparation


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Sterile products are prepared following specifiedprocedures which assure that they are:

Therapeutically and pharmaceutically appropriate to thepatient.

Free from microbial and pyrogenic contaminants.

Free from unacceptable levels of particulate and othertoxic contaminants.

Correctly prepared.

Properly labeled, stored, and distributed.


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Sterile products

preparationrequirements


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(1) PHYSICAL REQUIREMENTS:

A. Space:

z The facility shall have a designated area with entryrestricted to designated personnel for preparingcompounded sterile products. This area shall bedesigned to avoid unnecessary traffic and airflowdisturbances from activity within the facility.

z

This designated area shall be used only for thepreparation of these specialty products. It shall be ofsufficient size to accommodate a laminar airflow hoodand to provide for the proper storage of drugs andsupplies under appropriate conditions of temperature,light, moisture ,sanitation, ventilation, and security.


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B. Equipment:The facility shall have:

(1) Appropriate environmental control devices

capable of maintaining proper conditions in thework space where critical objects are exposedand critical activities are performed.

(2) Sink with hot and cold running water which isconvenient to the compounding area for thepurpose of hand scrubs prior to compounding.


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(3) Appropriate disposal containers for used needles, syringes,etc., and if applicable for cytotoxic waste from the preparationof chemotherapy agents, and infectious wastes.

(4) When cytotoxic drug products are prepared, appropriateenvironmental control also includes appropriate biohazardcabinetry.

(5) Refrigerator/Freezer with a thermometer.

(6) Appropriate delivery container including temperaturecontrolled container when needed.


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Horizontal Laminar Flow Hood

z Laminar flow hood,it will maintain an area free ofmicroorganism contaminants and particulate matter whenit is properly maintained, prepared, and used by operatorswith good aseptic technique.

z The use of good aseptic techniques is required at all times.

z If, for any reason the IV hoods are turned off, they must bereoperational at least 30 minutes before they are used to

prepare sterile products.

z Ampoules are bagged upon removal from the hood toprotect from traces of medication and sharp edges.

z Rapid movements are avoided while working in the hood toprevent disruption of the air flow.


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z Before beginning work in the hood, the interior bottom worksurface and two side surfaces are swabbed first with sterilewater for irrigation (allowing it to dry) and then 70% alcoholusing a side to side movement beginning at the rear edge of the

surface and working forward. Allow the alcohol to dry in orderfor it to exert the maximum bactericidal effect.

z Personnel work at least 6 inches inside IV hood and no closer

than 2 inches to the sides, back, and surface of the hood. Anymaterials that have been laid on the surface of the hood (forexample, needle with protective cap removed) are not reused.


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Preparation of Hazardous Sterile Products:

z All hazardous sterile products are prepared in the pharmacy in avertical flow hood

z The use of the vertical flow hood is limited to the preparation ofhazardous drugs.

z Additional attire is required for preparation of hazardous sterileproducts including specially provided gowns and latex gloves.

z Double gloving is required. Latex free gloves are recommendedto be worn under the latex gloves.

z All protective clothing is changed immediately uponcontamination by hazardous products.


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z Protective clothing is not worn outside the hazardoussterile product room.

z Protective clothing is disposed of in supplied labeled trashreceptacles.

z Disposable absorbent plastic backed paper liners are usedin the vertical flow hood and are changed at least everyshift or upon obvious contamination.

z

Approved chemo vents are used to prevent aerosolizing ofhazardous medications.


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z All contaminated preparation materials (i.e., gauze,usedsyringes, empty vials) are disposed of in the chemo trashcan.

z All contaminated materials (i.e., partially filled hazardousmedication vials and returned medications) are disposedof in the appropriately labeled supplied container.

z

A covered sharps container is located in the vertical flowhood. These containers have a label attached that says *Caution - Chemotherapy - Handle With Gloves. Dispose ofproperly*.


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z All doses of hazardous sterile products are delivered toinpatient units in ziplock bags labeled "Caution:Chemotherapy".

z

All personnel involved in the preparation of hazardoussterile products annually read and understand the latesteditions of the following publications which are available inthe Sterile Product Preparation Manual:

Work Practice Guidelines for Personnel Dealing WithCytotoxic (Antineoplastic) Drugs (Occupational Safetyand Health Administration (OSHA)).

ASHP Technical Assistance Bulletin on HandlingCytotoxic and Hazardous Drugs.


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z All hazardous sterile products are labeled with supplied warninglabels.

z Spills are only cleaned using supplied chemo spill kits utilizing

appropriate protective techniques.

z Syringes are no more than full when dispensing.

z All syringes are capped prior to removal from the vertical flow

hood.


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z Extremes of positive and negative pressure are avoided atall times to prevent spraying and aerosolizing ofmedications.

z

Manipulation of liquids in syringes is done within a closedenvironment, for example, a needle cover or the needleactually in a bag to protect the preparer from inadvertentexposure to hazardous medications, through spilling oraerosolizing of medication.

z Nothing is placed over the front vent grill. Thiscompromises the integrity of the hood's operationalcapacities and risks operator exposure to harmfulmedications.


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C. Supplies:The facility shall maintain:

(1) Disposable needles, syringes, and othersupplies needed for aseptic admixture.

(2) Disinfectant cleaning solutions.

(3) Hand washing agent with germicidal action.

D. Security:The facility shall provide adequate security for

all drugs.


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(2) PERSONNEL

A. Pharmacist In Charge:

Each facility shall be supervised by a

pharmacist who is knowledgeable in thespecialized functions of preparing anddispensing compounded, sterile

pharmaceuticals, including the principlesof aseptic technique and qualityassurance.


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B. Pharmacy Technicians:

The pharmacist-in-charge may be assisted bypharmacy technicians. These personnel shallhave specialized training in this field and shallwork under the immediate supervision of alicensed pharmacist.

C. Staffing:A pharmacist shall be accessible at all times ateach facility to respond to patients and otherhealth professionals questions and needs


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Preparation Room Attire:

z Personnel preparing sterile products are not allowed tohave or wear the following:

1. Fingernails in excess of inch

2. Artificial nails

3. Facial makeup

4. Hand jewelry

5. Particle generating clothing (fuzzy sweaters)


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z Personnel don the required attire in the following order:hair cover, mask, gown, and gloves.

z Gloves are put on last. The cuffs of the gown are placed

inside the gloves. (Note: double gloving is required forcytotoxic drug preparation.)

z Hands are washed with a bactericidal agent beforedonning and after removing gloves.

z Gloves are changed upon any obvious change in theintegrity of the gloves.


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z Masks cover all facial hair, if present, as well as nose andmouth. Masks are not allowed to fall below the nose.

z The required attire for preparation of sterile products issupplied in the ante room.

z Food, drinking, chewing gum, facial makeup, andexcessive talking is strictly prohibited in the sterile productpreparation areas.


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z Pregnant or lactating women, male or femalestaff who are actively trying to conceive a child,or staff with a medical condition that may

preclude them from handling cytotoxic drugs,have an option of whether or not they will handleor administer cytotoxic drugs.

z

Pregnant or lactating women will not prepareundiluted cytotoxic drugs.


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Preparation of IV admixtures

1- Admix all routine parenteral fluids in the pharmacy

in a laminar-flow hood using aseptic technique

Do not use any container of parenteral fluid that

has visible turbidity, leaks, cracks, or particulate

matter or if the manufacturers expiration date has

Passed.

2- Use single-dose vials for parenteral additives or

medications when possible.

3- Do not combine the leftover content of single-use

vials for later use.


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Ampoules - single dose containers:

With ampoule in upright position, tap neck gently to releasesolution trapped in the neck.

Wipe neck with sterile alcohol pad. When the ampoule is

broken, glass particles may fall into the ampoule.The neck mustbe clean.

Withdraw being careful.The needle must be changed aftercontact with the ampoule.


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If multidose vials are used:

1. Refrigerate multidose vials after they are opened ifrecommended by the manufacturer.

2. Cleanse the access diaphragm of multidose vials with 70%

alcohol before inserting a device into the vial.

3. Use a sterile device to access a multidose vial and avoidtouch contamination of the device before penetrating theaccess diaphragm.

4. Discard multidose vial if sterility is compromised.

5. Needle entry into vials with rubber stoppers is done

cautiously to avoid the creation of rubber core particles.


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Preparation of IV admixtures(cont.)

z To preserve the integrity of the clean room, pass-throughsare only opened from one side at a time. Both sides are notopened in order to communicate or pass materials directlyto personnel in the sterile product preparation area.

z Materials are not brought in and out of the IV room withoutdisinfecting before readmission. For instance, if the cart isrolled out of the IV room for restocking, it is disinfectedwith alcohol before readmission to the IV preparationroom.

z Labels are completed, when possible, before admission tothe IV preparation area. This includes dating and initialing.Labels are not placed in the hood or written on in the hood.


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z Preparation bins are not placed within the laminar flowhoods. All materials are kept to a minimum in the hood tomaintain the integrity of the laminar flow.

z Materials needed for compounding sterile products areplaced in supplied bins along with directions forpreparation or patient medication label.

z All materials are taken out of outer protective barriersbefore admission to the sterile product preparation area.

For example, bags are taken out of plastic outer wrap andvials are taken out of boxes.


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z All materials are kept at a minimum in the sterileproduct preparation room. Only materials thatare absolutely necessary for the preparation ofthe prodcut are in this area. Only one drug orpreparation is placed in each bin. If differentdoses are included in the same bin, they areseparated upon completion of preparation insuch a way that it is obvious to the checking

pharmacist how the doses were prepared (i.e., bybin separators). Only one medication or onedose is placed in the hood to be prepared at anygiven time.


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Labeling:

In addition to regular labeling requirements, the label shallinclude:

A. Parenteral products shall have the rate of infusion whenapplicable.

B. Expiration date.C. Storage requirements or special conditions.

D. Name of ingredients and amounts contained in eachdispensing unit.

Storage and Delivery:

The pharmacist-in-charge shall be responsible for theproper storage in the pharmacy of all sterilepharmaceuticals after they are compounded.


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Disposal of Infectious Wastes:

-The pharmacist-in-charge is responsible for

assuring that there are written policies and

procedures for safe collection and disposal of

any medical or infectious waste resulting from

the dispensing of sterile products.

-These policies and procedures shall extend to

any location where sterile products areadministered.


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Cleaning Procedures:

z The anteroom of the sterile product preparation area iscompletely cleaned at least monthly and recorded on theappropriate log sheet. This includes wiping down of everyshelf.

z All bins and carts used within the sterile productpreparation area are cleaned at least monthly anddocumented.

z Cleaning materials are made of materials that generate a

low level of particulate.


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z Environmental Services personnel sweep the floors dailyand then mop them with clean bactericidal water.Cleaningpersonnel don gowns, masks, and hair covers beforeentering the preparation area.

z Environmental Services personnel clean the walls andcleaning tiles in the sterile product preparation areas atleast weekly with clean bactericidal water.

z Trash cans are not emptied within the sterile product

preparation area. The trash cans are equipped with rollersso that they can be removed from the room when the trashneeds emptying by appropriately attired personnel withinthe area, or by appropriately attired EnvironmentalServices personnel.


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z Cleaning of IV hoods:

Hoods are cleaned at the beginning and end of each batchand when obvious contamination is observed. Cleaning isdone first with sterile water and then alcohol.

Cleaning of prefilters and under grill is done monthly andrecorded on the appropriate chart.This is done by trained IVroom personnel.

Cleaning of the vertical flow hood is done on a monthly basisby trained personnel only and is recorded on the appropriatelog sheet.


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z The exhaust fan / blower is cut off during cleaning.

z The operator wears a disposable gown, disposable latex

gloves covered by disposable utility gloves, safetygoggles, hair covering, and a disposable NIOSH - approvedrespirator. Gloves are changed immediately if torn.

z Close and remove sharps container from the chemo hood.

Discard and replace with new container after cleaning.


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z Decontamination is done from top to bottom(areas of lesser contamination to greater) byapplying the cleaner, scrubbing, and rinsingthoroughly with distilled or deionized water.

z Removable parts of the cabinet are cleanedwithin the containment area of the cabinet andare not removed from the cabinet. The work tray

usually can be lifted and placed against the backwall for cleaning of the undersurface of the trayand exposure of the bottom of the cabinet.


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z The outside of the cabinet is wiped down withcleaner to remove any drip or touchcontamination.

z

All contaminated disposals are contained insealable bags for transfer to larger wastecontainers.

z Final cleaning is done with 70% alcohol before

any aseptic procedure is begun.


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Quality Assurance (QA) / QualityControl (QC) Program:

z Process Validation

z End Product Testing

z Personnel Performance Validation

z Equipment Validation

z Environment Validation


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End Product Testing:

Low and Medium Risk:

End product testing is performed each month, twoproducts from each sterile product dispensing area aretested for sterility. If growth is detected, the entire sterile

preparation process is evaluated, corrective action taken,and a process simulation test performed.

High Risk Medications:

An appropriate sample of prepared sterile product is

inoculated and incubated for 14 days at the correcttemperature to document sterility of batch preparation.This is used for batch preparations, for example, talc,sodium benzoate.


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infection control in pharmacy

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