Pharmacies are regulated by state boards of pharmacies, which may choose to adopt USP standards. Individual institutions or institutional accrediting bodies may also adopt or endorse USP quality standards for sterile compounding.
B. Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH) develop guidelines and regulations related to sterile compounding, hazardous drug handling, and use of PPE to ensure workplace safety.
III. Preparing Intravenous Admixtures and Other Sterile Products
Technicians may help prepare sterile IV fluids containing drugs, vitamins, or other nutrients for hospital inpatients or outpatients.
A. Aseptic (sterile) technique
Compounding IV solutions, other types of injections (intramuscular, subcutaneous, etc.), ophthalmic and otic products, and preparations that will be instilled directly into the patient’s body tissues (e.g., irrigation solutions) requires strict adherence to aseptic technique to prevent contamination by microorganisms.
- Each institution and ambulatory pharmacy has written policies describing the proper use of aseptic technique. This type of compounding usually takes place in a separate sterile compounding room or in a specially designated area in the pharmacy. Correct use of aseptic technique involves proper attire, efficient hand washing, sterilization of the compounding surface (horizontal or vertical laminar airflow hood), aseptic preparation of the sterile products, and sterile maintenance of the compounding area.
a. Proper attire for sterile technique
(1) Proper attire for pharmacists and technicians preparing sterile products consists of a sterile gown, sterile gloves, a face mask to cover the nose and mouth, and a cap to contain and cover the hair.
b. Hand washing
(1) Before preparing sterile products, technicians must wash their hands thoroughly using chlorhexidine or another disinfectant.
c. Sterilization of the compounding surface
(1) The sterilizing agent may vary by institution or pharmacy. Ethyl alcohol (ethanol) and isopropyl alcohol (isopropanol or “rubbing alcohol”) are the most commonly used agents. To sterilize the compounding surface, pour alcohol in a thick layer on the hood surface, wipe down the surface with sterile gauze from back to front, and leave it wet until the alcohol evaporates. Leaving the compounding surface wet allows enough time for the alcohol to kill microorganisms that may live on the surface.
d. Sterilization of the injection sites on the additive containers
(1) Similarly, saturate the injection site on the additive vial with an alcohol preparation. Then, wipe the site with sterile gauze to clean the area where the needle gets inserted to inject, reconstitute, and withdraw the additive.
e. Maintaining the sterility of aseptic preparation materials
(1) While preparing aseptic products, take care to keep all surfaces and materials sterile. Make sure that they do not come into contact with other surfaces that may not be sterile, or surfaces that may be contaminated with other medications or substances.
f. Infection control standards
(1) The sterile compounding room or area must be scrupulously and continually maintained to ensure that all products are prepared in a completely aseptic environment. Pharmacies must conduct mandatory periodic tests to ensure that this area is properly maintained and contamination-free.
g. Preventing and treating unintended exposure to hazardous substances
(1) Sterile compounding may require handling hazardous drugs or other substances. In these cases, the compounding equipment should include supplies and information appropriate for managing hazardous substances (e.g., eyewash kit, spill kit, Material Safety Data Sheets). Chapter 13 contains more information on storage, handling, and disposal of hazardous drug substances.
B. Compounding sterile preparations
- Procedures for preparing IV admixtures and other sterile products can be found in a variety of sources. Section VII details calculations related to the preparation of IV solutions.
- Reconstitution
a. Many drugs are stored in the pharmacy as sterile powders that require reconstitution. Using aseptic technique, inject an appropriate amount of diluent (most commonly normal saline) into a vial for reconstitution. Then, shake the container and leave it on the hood surface until every particle of the powder has dissolved and the resultant solution becomes clear. Then, withdraw the solution from the vial and inject it into a larger volume of sterile solution. In some instances, the medication will be withdrawn and dispensed in a labeled syringe that is injected directly into the patient, or into another IV the patient is receiving.
- Ampules
a. Ampules
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