Infection Control Guidelines for Pharmacy [compatibility mode]

KING KHALID HOSPITALINFECTION PREVENTION

ANDCONTROL MANUAL

PHARMACYDr. Nahla Abdel Kader, MD, PhD.

Infection Control Consultant, MOHInfection Control CBAHI Surveyor

Infection Prevention Control DirectorKKH.

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DEFINITION

To provide clear guidelines for pharmaceutical staff on the correct procedures for preparation, storage and monitoring of sterile products compounded in the pharmacy and to prevent contamination of sterile products prepared in the pharmacy

COMMENTS

is in use

Patient morbidity and mortality can result from contaminated pharmaceuticals items.Sterile pharmaceutical products can become contaminated via:1. Intrinsic contamination, which occurs during the manufacturing process.2. Extrinsic contamination, which occurs subsequent to manufacturing; during the admixture process or while the infusate is in use

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A. Aseptic Technique:1. Failure to utilize aseptic technique can result in

contamination of pharmaceuticals, and has been associated with epidemics.

2. Remove any hand/wrist jewelry and scrub nails, hands and forearms with an antimicrobial soap before handling sterile products.

3. Do not eat, drink or smoke in the preparation area.4. Avoid touch contamination of sterile supplies.5. Wear a gown, facemask, shoe covers, hair covers, and

where applicable a cover for facial hair upon entering the preparation area .

6. Personnel engaged in compounding intravenous (IV) admixtures should wear sterile gloves. Gloves should be removed when exiting the preparation area. Gloves personnel should not answer the phone.

7. Procedures should be developed to validate the aseptic technique for each person preparing sterile products, and repeated at periodic intervals

PROCEDURE

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B. Engineering Controls:Process: All sterile products should be prepared in a class 100

environment, no greater than 100 particles per square foot, which can be achieved with the use of a certified vertical or horizontal laminar airflow hood.

Use of the Laminar Airflow Hood (LAFH)1. Operate the LAFH continuously. Before processing sterile

products therein, it should be in operation for a period of time long enough to purge room air from the work area ( at least 30 minutes or as per manufacturers’ recommendations).

2. Do not disrupt the air flow between the HEPA filter and any sterile objects to avoid contamination.

3. Complete all work at least 6 inches inside the LAFH.

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4. Disinfect the work surfaces and all accessible interior surfaces of the hood with a hospital approved disinfectant before begining work.

5. Clean the exterior surfaces of the hood daily with a hospital approved disinfectant.

6. Inspect the containers of the ingredients used to compound the sterile product for defects, product integrity and the expiration date noted.

7. Do not use defective products or expired products.8. Defective products should be reported to the Ministry of

Health using the Drug Quality Report.9. Disinfect the entire surface of all ampoules, vials and

containers with 70% Isopropyl Alcohol before entry into the LAFH and allow to air dry.

10. Handle all ampoules, vials, needles and syringes in such a way as to maintain asepsis and avoid unnecessary turbulence within the LAFH.

11. Ensure annual certification of the LAFH, or more frequently as needed and maintain certification records

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C. The Sterile Product Preparation Area:

1. Should be functionally separate from other areas.2. Should have a controlled air flow under positive

pressure that should not be disrupted by air ducts, vents or excess traffic that could produce air currents introducing contaminants.

3. Should be free of particle shedding materials such as cardboard boxes, or powdered gloves. Such materials should not be stored in any area surrounding the hood.

4. Should not have carpets, drapes and other particulate –shedding materials in the preparation area.

5. Should be with minimal personnel traffic and confined to those persons directly engaged in IV admixture procedures, or their supervision

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D. Quality Control Monitoring:1. Examine the final sterile product for any leaks, cracks,

turbidity or particulate matter.2. Label all admixed parental fluids to include the following

information:a. Patient Nameb. Medical record number, patient location.c. Solution and ingredient names, and concentrationsd. The administration regimen names, and concentrationse. The expiration date and timef. Storage requirementsg. Identification of the responsible pharmacist by badge

numberh. Appropriate additional labelling, for example any

precautionary measures that need to be taken.i. Device specific instructionsj. Any additional information in accordance with local

regulations or requirements

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E. Storage:

The pharmacy is responsible for the appropriate storage of pharmaceuticals throughout the institution. The following applies to parenteral admixtures:

1. Store admix parenterals according to the manufacturers’ recommendations.

2. Remove expired medication from patient care areas and correctly dispose.

3. Store admixed parenterals in the refrigerator for up to 1 week providing refridgeration begins immediately after preparation and is continuous. The stability of admixed ingredients may dictate a shorter or longer refridgeration period.

4. Follow manufacturers’ recommendations

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F. Pharmacy Responsibilites Involving Antimicrobial Control:

Concerns about antimicrobial resistance causing increased morbidity, mortality and healthcare costs have led to recommendations to control antimicrobial use.

1. Establish a system to control and monitor antimicrobial usage.

2. Participate in the development of programs for formulary and antimicrobial control.

3. Collaborate with physicians regarding patient specific recommendations for antimicrobial use

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G. Multidose Vials (MDV’s):

1. MDVs should be used and stored according to manufacturers’ instructions.

2. MDVs should be labeled with the opening date.3. MDVs should be discarded when:

a. Emptyb. The expiration date is reachedc. Suspected or visible contamination of the vial

4. The rubber stopper of MDVs should be wiped with Isopropyl Alcohol 70%, and allowed to air dry before needle insertion.a. Avoid touch contamination of the MDV.

5. MDVs should be accessed with a sterile needle each time and the needle removed on completion.a. The needle should not be left as permanent access, as it

will provide a portal of entry for micro-organisms

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