TITLE/DESCRIPTION: Pharmacy DEPARTMENT: Pharmacy PERSONNEL: Pharmacy Personnel EFFECTIVE DATE: 1/97 REVISED: 4/97, 7/08, 12/11, 1/15 I. PURPOSE To provide information about the role of the pharmacy in Infection Prevention and Control. II. POLICY It is the responsibility of the pharmacy department to insure that therapeutic materials prepared and dispensed in the hospital are free from infectious agents by strict adherence to aseptic technique and routine Infection Prevention and Control procedures. Springhill Medical Hospital Pharmacy is U.S. Pharmacopoeia (USP) 797 Compliance. The pharmacy production area will adhere to Good Manufacturing Practices, a complete control program, and utilize a strict quarantine system for manufactured products. The Pharmacy and Material Management shall have access to the lot numbers of all medications shipped to the institution so that fluids can be traced if contamination at the time of manufacture or during admixture in the pharmacy is suspected. Safe injection practices are required to prevent transmission of infections in patients. III. PROCEDURE A. General Good pharmaceutical service provides a variety of safeguards for the patients against the acquisition of a hospital-acquired infection. This is especially true with the trends toward continuous intravenous therapy and the increased use of complex intravenous admixtures, hyperalimentation therapy, and other sterile products needed in sophisticated drug therapy. Pharmacists are uniquely qualified by education and training to assist in the formulation of policies dealing with rational drug therapy and the proper use of disinfectant and related agents. Medical and hospital administrative professionals have a long historical awareness of the complex infection interrelationships in the hospital setting.
Employee health programs have been strengthened, with emphasis with education and prophylactic immunizations, and enhanced awareness of the employee as a factor in the spread of infection. B. Safe Injections Practices The following recommendations apply to the use of needles, cannulas that replace needles, and, where applicable intravenous delivery systems. 1. Use aseptic technique to avoid contamination of sterile injection equipment. 2. Do not administer medications from a syringe to multiple patients, even if the needle or cannula on the syringe is changed. Needles, cannulae and syringes are sterile, single-use items; they should not be reused for another patient or to access a medication or solution that might be used for a subsequent patient. 3. Use fluid infusion and administration sets (i.e., intravenous bags, tubing and connectors) for one patient only and dispose appropriately after use. Consider a syringe or needle / cannula contaminated once it has been used to enter or connect to a patient s intravenous infusion bag or administration set. 4. Use single-dose vials for parenteral medications whenever possible. 5. Do not use bags, bottles of intravenous solution, or single-dose vials as a common source of supply for multiple patients. Single and Multi-dose Vials A single dose vial is one, which is labeled as such by the manufacturer - normally the product labeling has no documentation of the presences of a preservative. Single dose containers shall be used for admixture when possible. Vials are preferred to ampules. Beyond-use time of six (6) hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry. Single dose vials shall be discarded at the end of each shift regardless of when opened during the shift. Ampules and the remaining product shall be discarded after single use. The container shall not be used as a reservoir for multi-dose unless the doses are drawn in an uninterrupted fashion. Do not administer medications from single-dose vials or ampules to multiple patients or combine leftover contents for later use. When multiple-dose vials are used more than once, a new needle and new syringe must be used for each entry. Do not leave needles or other objects in vial entry diaphragms between uses, as this may contaminate the vial s contents. Multi-dose vials must be discarded when empty, when suspected or visible contamination occurs, when deterioration is suspected, or when particulate matter is present. Once opened, multi-dose vials must be given an expiration date of 28 days unless otherwise specified by the manufacturer's expiration date, whichever comes first.
Do not keep multi-dose vials in the immediate patient treatment area and store in accordance with the manufacturer s recommendations; discard if sterility is compromised or questionable. For powders that are reconstituted, an expiration date is calculated based on the manufacturer's recommendation stated on the vial or in the insert or 28 days, whichever comes first. When vials will be re-used, the expiration date shall be placed on the vial. Multi-dose vials must be discarded that have been stored improperly. The assigned expiration date of multi-dose vials may be shorter than that of the manufacturer. However, under no circumstances will an assigned expiration date exceed the manufacturer's expiration date. C. Procedures in Pharmacy Main Dispensing Area Gloves shall be used when handling medication during prepackaging into unit dose packages. Cardboard boxes will be opened in the rear of the Pharmacy storeroom. Shipping boxes are not allowed to be stored in the Pharmacy. Pharmacy personnel will prevent the accumulation of any bulk containers that would impede proper cleaning of the area. Storage shelves, drawers and stock bottles will be dusted at frequent intervals. All utensils, equipment used in pharmacy preparation will be washed with detergent and thoroughly rinsed. All medications dropped on the floor or contaminated in any other way are to be discarded. When pouring liquid medications, care should be taken that the lips of the bottles do not touch. All compounding of stock solutions and prescriptions will be done using clean technique as appropriate. All sterile preparations will be prepared under the Compounding Aseptic Isolator (CAI) or vertical flow hood but only with a 12 hour stability of the product. All drugs shall be stored in clean, dry, dust-free areas. Bulk drug packages shall not be placed directly onto the floor, but elevated on shelves or pallets 8-10 inches off the floor. Control numbers assigned by the manufacturer to all drugs compounded, packaged and/or dispensed by the Department will be used in order that they can be traced should a contamination or product integrity problem develop. Expired medications should be removed from patient care areas and disposed of properly. Counting Trays
Bare hands should never be used to count drugs. Counting trays and spatulas are to be cleaned with a hospital approved disinfectant at least once daily and more often if needed. Admixture Service All persons working with sterile products must be familiar with all products, procedures, techniques, equipment and facilities required and available, so as to prepare the most efficacious product. Precautions shall be taken to reduce the possibility of contamination. It has been shown people are one of the greatest sources of particulate matter and hence bacterial contamination. No carpet, drapes or other particulate generating material is acceptable. Any Pharmacy Tech found to have a respiratory infection or any condition which would prohibit exercising good aseptic technique will be assigned to an area other than IV preparation for the duration of the illness. Personnel should clean hands and forearms with an antimicrobial soap before preparing sterile products. Gloves shall be used if any employee has cuts or open wounds on the hands. Sterile gloves must be worn when working in the CAI. Eating, drinking, and smoking should not be allowed in the preparation area. Aseptic technique must be used must be used for IV admixing. The handling of sterile products requires a comprehensive knowledge of aseptic technique and no person shall attempt to work with such products until he/she has been properly trained. Only Registered Pharmacists thoroughly trained in aseptic technique and parentally certified will prepare IV fluids without supervision. Registered technicians who have been nationally certified and successfully completed an IV Training program may prepare IV fluids under the supervision of the pharmacist. The sterile preparation area should be one where airflow and personnel traffic are limited. The hood should be a limited access area, separate from other pharmacy areas. Total parenteral nutrition fluids shall be admixed (compounded) in the pharmacy. Compounding of sterile products should be performed under vertical flow hoods; this includes adding of any additional substance to an IV solution and drug reconstitution.
The preparation of hyperalimentation solution or the addition of a product to a commercially prepared solution should be performed under vertical airflow. Irrigating fluids should be mixed under the vertical flow hood. Sterile supplies shall be transported in such a way as to prevent contamination, such as puncturing a container or alteration of a wrapper. The containers of ingredients used for compounding the sterile product should be inspected for defects, expiration date, and product integrity. Color, clarity, presence or absence of precipitate shall resemble the normal state. The entire surface of ampules, vials, and container closures must be disinfected appropriately before placement in the laminar-flow hood. The rubber stopper of containers should be wiped with 70% alcohol before entry. Automated devices used for compounding sterile products that are placed in the laminar flow hood should first be disinfected. The final sterile product should be examined for any leaks, cracks, turbidity, or particulate matter. Preparation of IV Fluids Scrub hands and arms thoroughly with antimicrobial soap before working in the hood and when personnel return from areas outside of the admixture area. Inspect I.V. bags or containers before use for particulate matter, cracks, vacuums and etc. The syringe, hands, etc., should be kept downstream from the I.V. being prepared. Single-dose vials whenever possible for admixture of parenteral products. If there is any doubt that a sterile product may have been contaminated, discard the product and start over. Admixture parenterals are stored in compliance with USP 797. Depending on the sterile product preparation procedures used and the storage temperature, the admixed parenteral products may be stored for longer periods of time. Once in use, all parenterals should be discarded or completely used. Lipid emulsions should be completed within 24 hours of starting. However, it should be noted that same manufacturers recommend 12-hour infusion times when the IV lipid emulsion is not a part of a total nutrient admixture.
Irrigation fluids, such as saline for irrigation and water for irrigation, should be discarded 24 hours after opening. The recalculated expiration date shall be place on the container. The pharmacy should monitor for appropriate storage of pharmaceuticals throughout the institution. Equipment Air conditioner filters should be changed or cleaned monthly to reduce amount of dust and dirt in the environment. Laminar Flow Hoods with Vertical Flow Care of hoods: The work surfaces and all accessible areas of the hood should be disinfected with a hospital approved disinfectant before work begins and periodically thereafter several times per day since the hood is in continuous use. Plexiglas side panels should be cleaned daily with alcohol. Introduction of non-sterile objects into the hood shall be avoided whenever possible. Traffic in the hood area shall be kept to a minimum. The pressure gauge shall be visually checked periodically to determine that the airflow velocity of the hood is within the recommended range. The operational efficiency of each hood should be inspected and certified every six months or when moved. Additionally the hood should have routine filter changes. Use of hood: The hood should run 24 hours a day. Vertical airflow hoods should be operated continuously before processing products in the hood, it should be in operation for a period of time long enough to purge roam air from the work area. To avoid turbulence that could introduce contaminated air into the hood, work at least six inches within the hood. Personnel preparing sterile products should wear special clothing covers that generate large amounts of particles. It is recommended to use protective clothing covers including gloves, gowns, masks, and covering forehead and facial hair. Double gloves and gowns shall be worn when working with chemotherapy agents.
Only equipment necessary (minimum number of objects, vials, and other containers) for each procedure should be placed under the hood. Arrange articles and work flow to avoid the flow of clean air over dirty articles, thereby contaminating other articles which must remain sterile. To insure an unimpeded airflow, place large articles toward outside of work area. Exterior surfaces of the hood should be cleaned periodically. Storage of Pharmaceuticals Temperatures of refrigerator, freezers, and warmers used to store pharmaceuticals should be closely monitored and recorded daily. Note: Temperature of refrigerators storing vaccines should be monitored and recorded twice daily. See Refrigerator, Food, Medications, and Specimen policy on further details. All refrigerators will be thoroughly cleaned with approved hospital germicide. Environmental Sanitation Food and drink will only be permitted in the break room. Floors should be maintained and a daily basis using a hospital approved disinfectant. Work surfaces, bench tops and counter tops should be cleaned daily with a hospital approved disinfectant. The Pharmacy shall clearly label germicides, disinfectants, etc., with warnings regarding shelf-life, safety, and other information as necessary. Storage shelves should be maintained routinely to be kept clean and dust free. Pharmacy personnel should check medical stations outside the Pharmacy on a routine basis. Employees should report major spills or environmental concerns to the Infection Prevention and Control or Environmental Services Supervisor. Bacteriological monitor will be done at the discretion of the Department Director and only with the Infection Prevention and Control Director approval. Supervisory Infection Prevention and Control Functions The Pharmacy should be the ready source in the hospital for information about anti-infective agents.
The Pharmacy should consult with the Infection Prevention and Control Director or Pharmacy and Therapeutics Committee as needed regarding the dosage and proper use of anti-infective agents. The Pharmacy and Infection Prevention and Control Personnel should work together in providing information to the Medical Staff about current use of antibiotics, antibiotic stewardship, and other anti-infective agents. Traffic Control Only authorized personnel may enter the Pharmacy.