Cert Exam 5e Chapter 7

[Audio] Welcome to the Certification Exam Review Fifth Edition presentation for chapter seven..

[Audio] Chapter 7: Sterile and Hazardous Compounding.

[Audio] At the end of this chapter, you will be able to: Discuss United States Pharmacopeial Convention (USP) guidelines for sterile and hazardous drug compounding processes. Differentiate between the different types of parenteral administration. Know the components of Sterile Compounding Master Formulation Record. Know the requirements of personal protective equipment and aseptic technique for sterile compounding..

[Audio] Identify important calculations for sterile compounding. Determine product stability including date and signs of incompatibility. Define the role of the Occupational Health and Safety Administration, the National Institute for Occupational Safety and Health, and the US Nuclear Regulatory Commission in the protection of healthcare workers. Describe some of the key safety requirements and personal protective equipment for hazardous and nuclear compounding. Understand the basic requirements for handling and disposing of hazardous and nonhazardous pharmaceuticals..

[Audio] Section seven point one: Sterile Compounding for Parenteral Administration.

[Audio] To ensure the highest quality and safest possible sterile product, the United States Pharmacopeial Convention (USP) has set out guidelines for sterile compounding in the United States Pharmacopoeia, General Chapter <797> , more commonly known as USP Chapter <797>. According to USP <797>, compounded sterile preparations must be prepared in a cleanroom with monitored air quality attained and maintained through primary and secondary engineering controls. Compounding technicians must use sterilized equipment and tools while following a strict aseptic technique that includes protocols for handwashing, donning personal protective equipment, and careful manipulation of ingredients, containers, and C-S-Ps during the preparation..

[Audio] CSPs are generally administered through a parenteral route of administration. Injectable parenteral dosage forms are administered through four paths: Intravenous which means injected into a vein via an I-V line and catheter or syringe intradermal which means injected between the layers of skin via a syringe subcutaneous which means injected under the skin into the subcutaneous tissue via a syringe Intramuscular which means injected into a muscle vial a syringe or injection pen..

[Audio] A Master Formulation Record for sterile compounding should include the following information: • the name, strength, and dosage form of the C-S-P • the physical description of the final preparation • the identities and amounts of all ingredients and appropriate container-closure systems • the complete instructions for preparing the C-S-P, including equipment, supplies, and a description of the compounding steps.

[Audio] The B-U-D and storage requirements. The quality control procedures. The sterilization method, if applicable. and any other information needed to describe the operation and ensure its repeatability. ..

[Audio] The standard sterile compounding area required by USP <797> is separated into two rooms: a preparatory ante-room and a buffer room (also known as the cleanroom) that provides space for the sterile compounding workstations or benches. A C-S-P workstation is called a primary engineering control because it has high-efficiency particulate air or heppa filtered ventilation system to protect the C-S-Ps from contamination..

[Audio] The buffer room and ante-room have heppa ventilation systems called secondary engineering controls (SECs). The buffer room must have at least ISO Class 7 air, and the ante-room must have at least ISO Class 8 air. The common P-E-C for nonhazardous sterile compounding is called the horizontal laminar airflow workbench, also known as the hood. The ventilated airstream produced by the P-E-C and its hood create ISO Class 5 air quality in the DCA in the middle of the horizontal laminar airflow workbench. Nonhazardous sterile compounding can also be done in a PEC called a compounding aseptic isolator.It offers even more protection for the compounding process. The horizontal laminar airflow workbench must be cleaned and sanitized according to USP standards at the beginning of each compounding shift and before eac). The direct compounding area must be cleaned after every 30 minutes of continuous compounding and after any spill or surface contamination. The primary engineering control prefilters must be replaced every 30 days. The heppa filters must be recertified every six months or any time the primary engineering control is moved..

[Audio] ThePersonal Protective Equipment garbing process for sterile compounding personnel follows a hospital or organizational policy. A sample garbing and hand-washing policy involves removing all unnecessary garments and jewelry in the ante-room. After removing prohibited garments and accessories, a technician will put on PPE, in the following order: shoe covers, hair cover, and face mask. Then comes handwashing and arm scrubbing. Sterile gowns (with sleeves) and gloves are put on last because they must be the cleanest items; the gown goes on in the anteroom, and the gloves are donned in the buffer room. The gown must be clean, disposable, and nonshedding, with arms that fit snugly around the wrists. Goggles, face shields, a nonpermeable gown, and two pairs of chemotherapy gloves are recommended when making hazardous C-S-Ps..

[Audio] Section seven point two: Sterile Compounding Calculations`.

[Audio] Before preparing the C-S-Ps with aseptic technique, technicians need to do or to double-check the calculations required by the medical order and/or the Master Formulation Record in order to fill in the Compounding Record. It is essential to memorize the equivalents and metric conversions to be confident in these calculations. You will also need to know conversions from standard time to military time to interpret the labels for drug Administration times. Knowing how to translate temperatures in Fahrenheit to Celsius and back is essential for checking the refrigerator and freezer storage conditions for IVs. Some important calculations needed for sterile compounding include dosage concentrations, alligations, dilutions, base solution overfill, flow rates, and 24-hour supply for IVs..

[Audio] Section seven point three: The Sterile Compounding Process.

[Audio] After the various types of C-S-Ps and other I-Vs are prepared and labeled, they must be inspected once more by the technician and pharmacist and assigned a beyond use date or the manufacturer's expiration date on the label (if not preprinted), and signed off by both the preparer and pharmacist. As noted, USP <797> guidelines specify the procedures for the dating, labeling, storage, handling, packaging, and transporting of CSPs in the hospital or infusion pharmacy. Improper procedures could adversely impact the sterility or stability of the products..

[Audio] Beyond use date guidelines are based on the contamination risk or specific sterility testing provided by the hospital or manufacturer, as well as storage conditions and stability ratings. U-S-P <797> provides guidelines for risk levels depending on the number and sterility of ingredients, the presence or absence of preservatives, the number of transfers from vials or ampules, and the use of automated compounding devices. Since C-S-Ps may be compounded in anticipation of use, the longer a compound is stored, the greater the risk of microbial and pyrogen formation. Information about the Chemical stability of a C-S-P is found in the Master Formulation Record, the manufacturer's literature, or specific product testing. The technician checks to make sure there are no leaks in any of the I-Vs, precipitates, or incompatibilities, then lays out all the C-S-Ps and all the components used in the compounding for the pharmacist's approval..

[Audio] Section seven point four: Hazardous Compounding.

[Audio] Because of the special dangers involved in hazardous compounding, the Centers for Disease Control and Prevention (CDC) and Occupational Health and Safety Administration (OSHA) worked together to create the National Institute for Occupational Safety and Health (NIOSH), which has published the "NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings." A Safety Data Sheet (SDS), for each hazardous agent or investigational drug must be readily accessible in a compounding facility, so employees can see what they are handling and know what to do in the case of an accidental exposure or spill. The US Nuclear Regulatory Commission (NRC) regulates the medical use of radioactive materials to minimize radiation exposure to patients and healthcare staff..

[Audio] Because of the special dangers involved in hazardous compounding, the Centers for Disease Control and Prevention (CDC) and Occupational Health and Safety Administration (OSHA) worked together to create the National Institute for Occupational Safety and Health (NIOSH), which has published the "NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings." A Safety Data Sheet (SDS), for each hazardous agent or investigational drug must be readily accessible in a compounding facility, so employees can see what they are handling and know what to do in the case of an accidental exposure or spill. The US Nuclear Regulatory Commission (NRC) regulates the medical use of radioactive materials to minimize radiation exposure to patients and healthcare staff..

[Audio] Hazardous drugs and sterile hazardous drugs must be compounded away from sterile products in a containment secondary engineering control area with an exterior venting system. Containment secondary engineering control areas must provide negative pressure, with the ventilation system causing unidirectional airflow that is suctioned out of the buffer room and away from the compounding technicians and outer rooms. A sink must also be available for handwashing and for emergency access to water. An eyewash station within the contained HD compounding area is necessary for removal of HDs from the eyes and skin..

[Audio] In general, the standard HD PPE, including eye and face protection and chemotherapy gloves, should always be worn for cleaning, disinfecting, decontaminating the C-P-E-Cs and C-A-C-Is, and deactivating H-Ds in the compounding area, using appropriate products. Chemical deactivation of a nonnuclear H-D should be done with 2% sodium Hypochlorite. Alcohol is not an effective deactivating or HD cleaning agent..

[Audio] Section seven point five: Waste Handling and Disposal.

[Audio] Sterile and hazardous compounding produce waste that must be disposed properly. During the admixture and administration of chemotherapy, any unadministered medication left in the IV bags and tubing, bottles, and vials must be disposed of in a hazardous waste container with a yellow label identifying it as hazardous waste. The US Environmental Protection Agency defines hazardous waste as waste that causes or contributes to an increase in mortality or an increase in irreversible or incapacitating reversible illness. Unused medications at healthcare facilities, pharmacies, and patient homes should not be flushed down the toilet or sink. Certain types of pharmaceutical waste are more dangerous than others, such as used fentanyl transdermal patches and other controlled substances. Because of their danger to children and pets, these patches should be folded in half and put into a sealed container with unappealing food waste like coffee grounds or cat litter and then put into a sealed trash container, away from child access..

[Audio] This concludes the Certification Exam Review Fifth Edition presentation for chapter seven..