Compounding 1 Flashcards
Who sets the standards for compounding?
USP
USP 795, 797, and 800 are considered the
minimal acceptable standards
Hospital pharmacists rely on the __________for guidance on implementing USP standards
American Society of Health-System Pharmacists (ASHP)
Non-Sterile compounding is used to:
1.) Prepare a dose or formulation that is not commercially available.
2.) Avoid an excipient.
3.) Add a flavor
Non sterile compounded preparations
PO, via tubs, rectally, vaginally, topically, nasally, in the ear
Simple non sterile compounding
Requires following instructions (using a compounding kit, etc.)
Moderate non sterile compounding
Involves specialized calculations or procedures or making a product with no established stability data
Complex non sterile compounding
Requires specialized training, equipment, facilities, or procedures
Example- transdermal
Non sterile compounding physical space requirements
Space should be specifically designed for non-sterile compounding.
Can be ambient (room) air, but must be separated from the dispensing part of the pharmacy.
Everything must be stored off the floor.
Two types of water needed
What is purified water used for in non sterile compounding?
Water-containing formulations, rinsing equipment and utensils
Which formulations require sterile compounding?
IV
IM
SC
Eye drops
Radiopharmaceuticals
Irrigations
Inhalations
Who sets the standards for air quality?
ISO
What is air quality determined by?
Particles per volume of air.
The lower the particle count, the cleaner the air
Air quality in critical areas for sterile compounding
ISO 5
(closest to exposed drug)
Particles are included in the air quality count if the are
0.5 microns or larger
Buffer area for sterile compounding
ISO 7
Anteroom for sterile compounding
ISO 8 if non hazardous
ISO 7 if hazardous
Particles in ISO 5 environment
3,520
Particles in ISO 6 environment
35,200
Particles in ISO 7 environment
352,000
Particles in ISO 8 environment
3,520,000
HEPA filters are ___________efficient at removing particles ______
> 99.97%
as small as 0.3 microns
Where is the HEPA filter in a vertical airflow BSC or CPEC?
At the top
Where is the HEPA filter in a laminar airflow workbench or PEC?
At the back
Horizontal airflow
Direct compounding area
Cleanest air where compounding is done.
The air is called first air
How often must a HEPA filter be recertified?
Every 6 months by a specialist and anytime the PEC has moved
Wipe the outside of materials with _________before putting into the PEC
70% isopropyl alcohol (ISA)
Physical space requirements for sterile compounding
Surfaces must be smooth and impervious to make the easy to clean and disinfect. Stainless steel is often used
Cleanroom suite
ISO 5 PECs (sterile hoods) inside of an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom
Segregated compounding area (SCA)
ISO 5 PEC is often an isolator/glovebox with a closed front. Located in a space with unclassified air.
The PEC is a device that provides
ISO 5 air
Sterile hood most common
Compounding aseptic isolator (CAI)
Closed front PEC that is often located in a segregated compounding area (SCA)
Minimal hygiene that must be performed when using a compounding aseptic isolator
Hand hygiene
Sterile, powder free gloves inside the CAI
Max BUD of a compound prepared in a segregated compounding area
12 hours
Who determines which drugs are HD?
NIOSH
HD are
Carcinogenic
Teratogenic
Genotoxic
Toxic to organs
Labeled by the manufacturer with special handling instructions
HD antibiotics
Chloramphenicol
HD anticoagulants
Warfarin
HD antifungals
Fluconazole
Voriconazole
HD antiretrovirals
Abacavir
Entecavir
Zidovudine
HD antivirals
Cidofovir
Ganciclovir
Valganciclovir
HD arrhythmias
Dronedarone
HD autoimmune
Acitretin, azathioprine, leflunomide
Fingolimod, teriflunomide
HD bisphosphonates
Pamidronate
Zoledronic acid
HD depression
Paroxdetine
HD diabetes
Exenatide
Liraglutide
HD dyslipidemia
Lomitapide
HD gout
Colchicine
HD hepatitis
Ribavirin
HD insomnia
Temazepam
Triazolam
HD migraine
DHE
HD PD
Apomorphine
Rasagiline
HD schizophrenia
Ziprasidone
SDS
Required to be accessible to all employees working with HD. Includes safety information for PPE, first aid, and spill clean up
Hazard communication plan
Designated individual creates
Must be written and include a confirmation in writing that all men and women of reproductive capability understand the risks associated with HD
Lower risk activities according to USP 800
Counting and packaging tablets
Assessment of Risk (AoR)
A pharmacy can conduct an assessment of risk for lower risk activities with HD.
SOPs must be developed with actions to limit staff exposure, such as:
-ASTM D6978-rated gloves
Can you perform an AoR for a HD that requires manipulation?
No, any manipulation of the drug needs to follow full USP 800
AoR documents must be reviewed
every 12 months
Hoods and buffer rooms with HDs include the work
containment
C-PECs for HD Compounding
Biological Safety Cabinets
Containment Ventilated Enclosures
Compounding Aseptic Containment Isolators
Biological safety cabinets
Have vertical laminar airflow and negative pressure
For sterile HD compounding, BSCs must be
Class II or III
Containment Ventilated Enclosures
For non sterile HD compounding only
Compounding aseptic containment isolators
Glovebox, located in SEC or C-SCA
Non-sterile and sterile HD compounding in the same space
C-SEC must maintain ISO 7
Sterile and non-sterile C-PECs must be at least 1 meter apart
What must have negative air pressure?
C-PECs
C-SECs
C-SCAs
Air changes per hour
Number of times that the air is replaced in the room
Non sterile HD ACPH
12 ACPH
Sterile C-SEC ACPH
30 ACPH
C-SCA ACPH
12 ACPH
Alternative option to external exhaust in non-sterile HD compounding
Redundant HEPA filters
Only for non-sterile
Storage of HD
Must be stored separately from non-HD drugs in a negative pressure room with at least 12 ACPH
Gloved fingerprint test
Required initially and annually if compounding low and medium risk CSPs
Required semiannually if compounding high risk CSPs
Evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers on TSA
Passing a gloved fingerprint test
Initially- requires 3 consecutive gloved fingerprint samples with 0 CFUs for both hands.
Ongoing- 1 sample with </= 3 CFUs
Media fill test
Used to determine aseptic technique
Performed initially and annually
Tryptic soy broth (TSB) takes the place of the drug in the preparation.
Turbidity=contamination
Check after 14 days of incubation
Temperature monitoring in the SEC
Must be checked once daily and maintained at 20 C or 68 F or cooler
Temperature monitoring of the refrigerator
Checked at least daily
Refrigerator: 2-8 C
Temperature monitoring of the freezer
Check at least once daily, twice if contains vaccines
No vaccines: -25 to -10 C
Vaccines: -50 to -15 C
Air sampling
At least every 6 months by a person certified or a qualified compounding staff member
Surface sampling
Test periodically at the end of the day
Tryptic Soy Agar (TSA) is a good growth medium.
Polysorbate 80 and lecithin are added to TSA to neutralize the effect of any disinfecting agents
Test anywhere exposed to staff- inside PECs and other work surfaces
Passing surface sampling
0 CFUs preferred
>3 CFUs- action must be taken in ISO 5 area
>5 CFUs- action must be taken in ISO 7 area
> 100 CFUs- action must be taken in ISO 8 area
Air pressure testing
Confirms there is a differential between the two spaces and that the airflow is unidirectional.
Must be check (minimum) of once daily or with every work shift
What should you do if a PEC is turned off?
Clean with a germicidal detergent and then disinfect with sterile 70% IPA
If it is a C-PEC, sanitization is needed
Must be on for at least 30 minutes before compounding can begin
Cleaning the PEC
Clean continuously
Lint-free sterile wipes are used
First clean with a germicidal detergent then disinfect with 70% IPA
Use overlapping, unidirectional strokes and replace used wipes often.
Clean top to bottom, back to front from the cleanest areas to the dirtiest.
Cleaning counters and floors
Clean with germicidal cleaner and disinfect with 70% IPA daily
How often to clean ISO 5 PECs
Before each shift
Every 30 min while working
Before and after each batch of CSPs
Whenever needed
What should be cleaned monthly
Ceiling
Walls
Shelving
Chairs
Bins
Carts
Sanitizing HD equipment
Deactivate
Decontaminate
Clean
Disinfect
How often does sanitization occur with HD compounding
At least once daily
Deactivation and decontamination agents
2% bleach (sodium hypochlorite)
Peroxide
Cleaning agents
Germicidal detergent- Quat, Ammonium, Phenolics
Disinfection agents
70% IPA
When using sanitization agents,
Wetted wipes are preferred
Must wear appropriate PPE
Agents that can be used for both deactivation and decontamination
Peridox
Bleach
Peroxide
If using bleach, must neutralize to prevent erosion
Bulk HD waste
Black bin
Trace HD waste
Yellow bin
Red bin
Non hazardous sharps
Where do syringes and needles go that were used with HD?
Yellow bin
Surface sampling for HD
Wipe sampling must be done at least every 6 months to ensure hazardous residue is completely contained.
Drug exposure
Get the drug or chemical off ASAP
- Immediately remove garb with drug on it
- Cleanse any affected skin
- If eye exposure, use eye wash for at least 15 min
- Obtain medical attention if needed
HD exposure and spill management
Eye and face protection must be worn if at risk for spills or splashes
Face shields in combo with goggles is preferred
Respiratory protection from HD
Elastomeric half-mask with a multiple gas cartridge and a P100 filter
N95 respirator is usually sufficient
If at risk for respiratory exposure wear:
-Fit tested respirator mask with attached gas canisters
-PAPR (powered air purifying respirator)
Where to find information on HD spills?
SDS
How to take care of HD spill
-Establish who, what, and when
-Place sign that says HD spill
-Spill kit
Spill kit contents
-Protective gown, latex gloves, N95 mask, goggles
-HD waste bag, chemo pads
-HD spill report exposure form
Procedure for cleaning up a HD spill
Put on heavy duty gloves over ASTM D6978 (chemo) rated hloves
-Put bulk waste in black bin
PPE when admin HD
2 pairs of chemo gloves for all HD
Chemo gown is required for administering IV HD
What must be used by nurses for HD admin?
Closed system transfer devices
What are chemotherapy pins for?
Prevent HDs from aerosolizing
Are CSTDs required for compounding HD?
No, recommended
CSTDs have a build in valve that
equalizes air pressure
If manipulation of oral HD is required,
Do in a plastic bag
Outer chemo drugs worn in HD compounding should be put in
yellow bin or in a sealable bag if not in C-PEC
Chemo gown and outer shoe covers should be
taken off before exiting the negative pressure room and plaecd in yellow bin
Pneumatic tube systems _______be used to transfer liquid HDs or antineoplastics
CANNOT
Garb for HD
Double chemo rated gloves
Single gloves could be used for receiving and storage
Non Sterile- double gloves, a gown, mask, and disposable pad to protect work surface
Sterile- Head cover, face mask, beard cover, 2 pairs of shoe covers, impermeable gown, 2 chemo gloves, full facepiece respirator or face shield with goggles
Garbing for sterile compounding
Dirtiest to cleanest
1.) Hair covers and mask, then show covers while stepping over line of demarcation.
2.) Hand hygiene using soap and warm water, clean under nails, circular motions for 30 sec
3.) Don non-shedding gowns
4.) Enter buffer area (SEC)
5.) Apply alcohol based surgical hand scrub
6.) Don sterile powder free gloves
7.) Sanitize with 70% IPA
What gowns are required for sterile HD?
disposable
How often to change HD gowns
At least every 2-3h or immediately after spill
