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CMB-Chapter 18

CMB - Chapter 18 - Sterile Product Compounding & USP Chapter 797

QuestionAnswer
On what date was the first United States Pharmacopeia (USP) Chapter 797 published? January 1, 2004
USP Chapter 797 contained the first enforceable sterile preparation compounding requirements in the US
On what date was USP Chapter 797 revised June 1, 2008
the June 1, 2008 revisions of the USP Chapter 797 included hazardous drugs, updated risk level classifications, updated garbing techniques
NABP National Association of Boards of Phamracy
ASHP American Society of Health-System Pharmacists
CSP compounding sterile preparations
These two organizations may enforce guidelines developed by USP FDA & JCAHO
PCAB Pharmacy Compounding Accreditation Board
USP Chapters 1 through 999 are considered requirements & enforceable by the FDA
USP Chapters 1000 through 1999 are informational & additional non-enforceable recommendations
USP Chapters 2000 & above apply to nutritional supplements
Some injectable medications must be compounded in a pharmacy because dosages are customized for each patient, some drugs are stable for only short periods of time
The process used to avoid contamination while compounding sterile products is known as "aseptic technique"
For injectable drugs, there are three primary routes of administration SubQ, IM, & IV
SubQ, SQ, or SC) injections consist of very small volumes of fluid (usually less than one or two mL) given just below the skin using a fine, short needle
Intramuscular (IM) injections employ small volumes of fluid & are delivered deep into muscle tissue by longer & larger-bore needles
Intravenous (IV) injectable are delivered directly into the vein
IV push medication delivered all at once
continuous infusion medication delivered slowly over a longer period of time, perhaps up to several hours or even days
Intra-peritoneal (IP) is an injection into the peritoneal cavity (abdominal) of the body
IP is more commonly used in animals
In humans, IP administration has been used as a means of dialysis or administration of chemotherapy agents
TPN Total parenteral nutrition
Total parenteral nutrition (TPN) is used when patients cannot consume food or nutritional formula (like Ensure) for a prolonged period of time
A patient with a resistant or chronic infection may need IV antibiotics
PCA patient controlled analgesia
patient controlled analgesia (PCA) device patients regulate the frequency of administration of their own pain medication
Small-volume parenterals contain just enough fluid volume to safely deliver the medication into a patient's vein
When a small-volume parenteral is compounded, the ?, ?, ?, and ? all must be calculated & double checked prior to beginning the compounding process correct drug, dose, dilution solution, number of doses
Many small-volume parenterals are delivered into the vein at the same time as another fluid, this is considered "on piggyback"
Large-volume parenterals are used when the fluid itself is the treatment
prescriptions for small-volume parenterals specify the frequency of administration
prescriptions for large-volume parenterals specify the rate of administration
All parenteral medications must be sterile
The "critical area" is defined as at least 6 inches within the laminar air flow hood
The critical area should be ISO Class 5 or better
The buffer area is from the room entrance to the 6 inch mark within laminar air flow hood
The buffer area should be ISO Class 7 or better
The anteroom or preparation room is the room just before the buffer area
The anteroom should be ISO Class 8 or better
The two basic types of laminar-flow hoods horizontal and vertical
Barrier isolators are closed devices & compounders are completely isolated from the compounded sterile product
To maintain sterility, while working in a horizontal laminar-flow hood you must always keep your hands & any nonsterile materials or supplies "downwind" from the product
one disadvantage of horizontal laminar-flow hoods they blow a mild current of air directly at the person doing the compounding, resulting in repeated contact with medications
vertical laminar-flow hood is also known as a biological safety cabinet
In a horizontal laminar-flow hood the clean air blows from the filter toward the person working in the hood
In a vertical laminar-flow hood the clean air blows straight down toward the work surface & is exhausted by a vent which surrounds the work surface.
sterile preparations compounded using non-sterile ingredients are always considered high risk
High risk= starting ingredients are non-steril, prep time is more than 6 hours, ingredients used >3, entries >2, & batch prep.
Immediate use= starting ingredients are steril, prep time is several minutes to less than 1hr, ingredients used < or = 3, entries < or = 2, & non-batch prep.
BUD beyond-use date
Low-risk CSPs with a 12-hour or less BUD are not required to have an anteroom or ante area with ISO class 8
Low-risk CSPs are generally prepared for a one-time dose, for one patient
Medium-risk CSPs are generally batch preparations
High-risk CSPs are sterile products compounded from non-sterile bulk ingredients or powders
CSPs are considered high risk if exposed to an environment worse than an ISO Class 5 for over 1 hour
An example of an event where an immediate use CSP is necessary is during CPR
Remember, hazardous CSPs shall ALWAYS be prepared in vertical laminar flow hoods (biological safety cabinets) or barrier isolators
If the Immediate use CSP is not administered within 1 hour, the CSP must be discarded
If the CSP is not administered immediately & completely, the CSP shall include a label listing the following Patient id info, Names & amounts of all ingredients, Name/initials of the preparer, Exact 1-hour BUD time
Examples of hazardous medications include those used in cancer, such as methotrexate, cyclophosphamide, and fluorouracil
Hazardous preparations are also recommended to be stored in a negative-pressure room
Environmental sampling will be done initially and then at intervals of at least every 6 months
NIOSH National Institute for Occupational Safety and Health
OSHA Occupational Safety and Health Administration
The Occupational Safety Act of 1970 created OSHA & NIOSH
OSHA is part of the U.S. Department of Labor
NIOSH is part of the U.S. Department of Health & Human Services
most important step to becoming compliant with USP guidelines Training personnel on aseptic technique, hand washing, and proper garbing (least expensive)
2nd most important step to becoming compliant with USP guidelines Personal evaluation
3rd most important step to becoming compliant with USP guidelines Monitoring for surface microbial contamination, temperature, and humidity
4th most important step to becoming compliant with USP guidelines Review primary engineering controls (e.g., laminar flow hoods)
5th most important step to becoming compliant with USP guidelines Remodeling facilities, updating cleaning & disinfecting procedures
every time you have to handle objects outside of the hood, you must wash your hands again before putting them back in the sterile environment of the hood
Laminar flow hoods & barrier isolators are to be cleaned when at the beginning of each shift, before each batch preparation, every 30 minutes during continuous compounding of a single CSP, and when contamination is suspected
Counters and work surfaces located in the buffer area and the anterooms are to be cleaned daily
Parenteral nutrition solutions administered peripherally are usually used as a supplemental source of protein and calories for patients who are able to take some nutrition orally
TPNs are typically given via a central line
TPNs are composed of several ingredients including carbohydrates, proteins, fats, water, electrolytes & other elements
Machines such as ? and ? use specific gravity and weights to fill TPN orders AutoMix and Exacta-Mix
Physical incompatibilities result in a noticeable visual change such as precipitate, color, cloudiness, or gas production.
Chemical incompatibilities occur when a product's composition is compromised often due to the presence of light or extreme temperature changes.
Therapeutic incompatibilities are interactions between medications that cause a change in the activity of either one or both of the medications.
Beyond-use dating (BUD) is defined as the time from the end of the preparation to the beginning of administration of a CSP
I define Beyond-use dating (BUD) as I make it, you take it time!
low risk BUD 48hrs Room; 14d Refer; 45d freezer
low risk w/12hr BUD 12h room; 12h refer
med. risk BUD 30h room; 9d refer; 45d freezer
high risk BUD 24h room; 3d refer; 45d freezer
immediate use BUD 1h room; 1h refer
Single-dose containers have the following BUD air of quality inferior to ISO Class 5:BUD less than 1 hr - ISO Class 5 air quality or better: BUD of 6hr
Multidose containers have the following BUD Opened or needle-punctured: BUD of 28 days
Sterile compounding requires a great deal of documentation, such as compounding process, materials used, controlled subs, inventory records, clean room maint, QA & QC, & patient records
Labels for sterile products usually contain the following pharmacy name, address, and telephone number, Patient name, Prescription date, prescriber name, Compounding date, Medication/additive name & strength, Diluent name & volume, Final volume, Sig/directions, Admin instruct, Date & time for admin of med, Pharm
An ? may be used in TPN compounding. This device combines a pump with an accurate balance automated compounder
A ? pump can ease the job of filling many small volume parenterals repeater
filter needles are used when medication from an ampule is used
Created by: cbowers101
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