Compounding sterile preparartions Flashcards
Injectable routes of drug administration bypass 3 of the body’s physiologic safeguards.
LIst them.
The gastrointestinal tract, or gut
The liver
The skin
Remember human touch (hands) is the most common source of contamination.
But why?
Injections expose the patient to bacteria, fungi,
and viruses on a health care worker’s skin.
Explain the Viability of Microorganisms
Why can microorganisms grow in IV preparation?
Bacteria can double their numbers every 4-20 minutes in favourable conditions (nutrients, temperature, pH, and osmolarity to thrive.)
fat emulsions and total parenteral nutrition provide better conditions for bacterial growth.
What are the sources of Microbial contamination?
Human touch (via Needles, Syringes, Vial tops, Ampoule openings)
Airborne contamination from (Aspergillus, Cladosporium, Penicillium, Alternaria, Candida)
Surface contamination e.g. (Water supply. Countertops, Floors, Walls and ceilings, Clothing, surfaces of compounding supplies, Packaging materials)
Contamination during storage from (Container cracks, Closure leaks, Bag punctures, Tubing leaks)
Single vs Multiple Use Containers.
Single use: no preservative, not bacteriostatic, larger than 30 mL
(e.g. IV bags and bottles, Prefilled syringes, Diluents such as “Sterile Water for Injection”, Propofol Antibiotic and chemotherapy vials)
Multiple use: preservatives, 28 day BUD according to USP
e.g. preservatives (Benzyl alcohol, Methyl and propyl paraben, Phenol)
List CDC Safe Injection Practices
- Do not administer medications from a syringe to multiple patients
- Only use fluid infusion and administration sets for one patient.
- Use single-dose vials when possible.
- Do not administer medications from single dose vials/ampoules to multiple patients or combine leftover for later.
- Needle/ cannula/ syringe used to access the multiple-dose vial must be sterile.
- Store multiple-dose vials properly
- Do not use bags or bottles of intravenous solution as a common source of supply for multiple patients
Why do pyrogens become contaminants?
Remember pyrogens are remnants of microbial metabolism, usually gram-negative bacteria
Molecules too small to filter
Too stable to destroy by autoclaving (moist heat sterilization)
What are the Risky Routes of Administration?
- Central nervous system
Epidural, Intrathecal, Intracranial - Joints
Intra-articular, Intrasynovial - Eye
Intraocular
What are the Patient-Related Risks?
Advanced age (non modifiable factor)
Obesity
Malnutrition
Diabetes mellitus
Cancer
Steroids and other immunosuppressants
Extended duration of intravenous catheters or other vascular access devices
Examples of Medication Errors
Incorrect dosage calculations by health care workers
Incorrect drug product, dose, and diluent
Incorrect preparation method
Absence of product labeling
Absence of preparation documentation
Improper storage prior to administration
IV Incompatibilities occur between___
drug and IV solution (if incompatible with dextrose use saline)
two drugs
a drug and its container(adherence)
a drug and light
United States Pharmacopeia Risk Level Examples
Immediate Use: Reconstitution of an antibiotic that is injected into an IV bag for which administration begins in less than an hour
Low risk: Simple aseptic measuring and transferring with not more than three packages of manufactured sterile products including the infusion or diluent
Low Risk with 12-hour or less beyond-use dates:
Low-risk compounded sterile preparations made in a laminar air flow workbench that islocated outside of an ISO Class 7 clean room.
Medium risk: reservoirs of injection or infusion devices with more than three sterile drug products and elimination of air from the reservoirs.
High risk: Non-sterile bulk drug or nutrient powders dissolved to make solutions that will be sterilized
General Procedures
- Read and confirm medication order details.
- Prepare areas beforehand
- Assemble all equipment and materials.
- use single dose vials when possible and do not use this single dose vials for multiple patients.
- Use new syringes for multiple dose vials and use dates to keep track.
- check integrity, expiration, storage
- beware of medications that have similar names.
- verify patient allergy, preparation, administration, medication order.
- Use aseptic technique
- follow protocols/procedures
- dispose of sharps in sharp containers
- dispose of expired according to protocols
- do not compound hazardous or complex admixtures (TPN) drugs in patient care areas.
How to determine a Beyond-Use Date?
manufacturer’s Expiration date
(shelf life if properly stored in original container)
Chemical and physical stability if compounded according to manufacturer labeling
Sterility minimizes microbial growth in case of inadvertent contamination
Stability versus sterility – Use the shorter!
What are the Primary Engineering Controls?
- Clean, organized medication preparation room
- Laminar airflow workbench
- Biologic safety cabinet
- Compounding isolator
Aseptic (positive pressure)
Containment (negative pressure)
What are the Barriers to bodily contamination?
Hand hygiene
Garb
Gloves
What should be labelled on an Injection?
- Name of the medicine
- Strength
- Route of administration
- Diluent and final volume
- Patient’s name
- Beyond-use date and time
- Name of practitioner preparing the medicine
How should you place a label on an IV bag?
Label on printed side of bag
Beneath the solution name
Slightly offset so that graduation marks can still be read
How to Checking Finished Preparation?
Then discard all waste
Have another qualified health care worker check that the work is correct as compared to original medication order:
