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Compounding I Basics
Ch 15
| Question | Answer |
|---|---|
| When do we compound drugs? | Typically for individual patients based on a prescription for medications that cannot be commercially available as a manufactured product |
| Are compounded drugs FDA approved like manufactured drugs? | No |
| Compounded drugs can be sterile and non-sterile and further subdivided into nonhazardous and hazardous. What determines if its non-sterile or sterile or if hazardous? | 1. The formulation determines if its sterile or non-sterile 2. The drug being used determines if its hazardous |
| What sets the standards for compounding preparations? | United States Pharmacopeia (USP) |
| What chapters in the USP are for non-sterile compounding? | USP 795 |
| What chapter in the USP are for sterile compounding? | USP 797 |
| What chapter in the USP are for Hazardous drug compounding? | USP 800 |
| Does the USP determine if the drug is hazardous or just how to compound with hazardous drugs? | Does not determine if a drug is hazardous rather just how to compound with them |
| What helps hospital pharmacists implement USP guidelines in the hospital? | American Society of Health-System Pharmacists *ASHP* |
| Non-Sterile Compounding *USP 795* is typically for what 3 things? | 1. Prepare a dose or formulation not commercially available - change solid to liquid, compounding 10% ointment from 5% and 15% available 2. Avoid excipients in manufactured products (Gluten.red dye) 3. Add a flavor to make it taste better |
| Non-Sterile preparations includes what routes of administration> | 1. Mouth 2. Tube 3. Rectally 4. Vaginally 5. Topically 6. Nasally 7. Ear |
| USP 795 divides non-sterile compounding by complexity what are those 3 divisions? | 1. Simple 2. Moderate 3. Complex |
| What is simple non-sterile compounding? | 1. Just following instructions (Like a recipe) |
| What is moderate non-sterile compounding? | 1. Involves special calculations or procedures or making preparations that has no established stability data like mixing two topical creams with no stability data when combined |
| What is Complex non-sterile compounding? | Complex requires specialized training, equipment, facilities, or procedures (Transdermal dosage forms) |
| For compounding space non-sterile needs special requirements for the space being used what are some examples> | 1. Can be performed in ambient air, must be separated from dispensing part of pharmacy 2. All components, equipment, containers must be off floor 3. Adequate plumbing of two types of water 4. Clean sink 5. Temperature control 6. Well lit/clean |
| What are the two types of water needed in non-sterile compounding and what are they used for> | 1. Potable water - drinkable such as tap water for hand and equipment washing 2. Purified water (Distilled) for use in water containing formulations and for rinsing equipment/utensils |
| Sterile compounding uses strict procedures to keep products from contamination, especially for injections into the blood stream. What are some preparations made with sterile compounding? | 1. Injections (IV, IM, SC/Sq) 2. Eye drops 3. Irrigations - liquid washes that go into body cavities 4. Pulmonary inhalations (NOT NASAL) |
| CSP meaning? | Compounded sterile products (IV or other sterile drugs) |
| SVP meaning? | Small Volume Parenteral (<100 ml) |
| LVP meaning? | Large Volume Parenteral (>100ml) |
| PPE meaning? | Personal Protective Equipment (Gowns, mask) |
| Don means what? Doff means what? | Don means put on Doff means take off |
| PEC meaning? | Primary Engineering Control - Sterile hood that provides ISO 5 air for sterile compounding |
| LAFW meaning? | Laminar airflow workbench - Type of PEC that has parallel air streams flow in one direction |
| What is C-PEC? | Containment Primary Engineer control - Ventilated (Negative pressure) chemo hood used for hazardous drugs |
| What is BSC? | Biological Safety cabinet its a chemo hood class II or III for sterile Hazardous drugs and is a type of C-PEC |
| What is SEC? | Secondary Engineering Control - a ISO 7 buffer room where the sterile hood PEC is located |
| What is C-SEC? | Containment Secondary Engineering Control - Ventilated negative pressure buffer room for HDs room where C-PEC is located |
| What is SCA? | Segregated compounding area - designated space that contains ISO 5 hood but is not part of a cleanroom suite as air is not ISO rated |
| What is C-SCA? | Containment segregated compounding area - ventilated negative pressure room used for HDs not in a cleanroom suite air not ISO rated |
| What is CAI? | Compounding Aseptic Isolator - Glovebox for for non-HDs a closed front sterile hood PEC |
| What is CACI? | Compounding Aseptic Containment Isolator - Glovebox for HDs a type of closed front C-PEC |
| What is RABS? | Restricted Access Barrier system - Glovebox/closed front sterile hood includes CAIs and CACIs |
| What is CSTD? | Closed System Transfer Device - a device preventing escape of HD/Vapors when transferring from a vial to syringe |
| What is CVE? | Containment Ventilated Enclosure Device - Ventilated Powder Hood for non-sterile products |
| T/F there are greater and stricter compounding space requirements for sterile compounding than non-sterile compounding | True |
| Who sets the air quality for sterile compounding? | International Standards Organization (ISO) |
| What determines air quality and ISO rating? | The number of particles per volume of air |
| T/F The lower the number of particles per volume of air the cleaner the air | True |
| What must the ISO be in critical areas I.E. areas closest to exposed sterile drugs and contains inside the sterile hood? | ISO 5 |
| The farther away from the PEC the dirtier the area what must the buffer area ISO be? | ISO 7 |
| What must the Ante Room area ISO be (the area next to the SEC where hand washing and garbing occurs) if it opens into a positive pressure buffer area? | ISO 8 |
| What must the Ante Room area ISO be (the area next to the SEC where hand washing and garbing occurs) if it opens into a negative pressure buffer area? | ISO 7 |
| What size particles are included in ISO Particles/volume of air? | Particles 0.5 microns or larger |
| What do HEPA filters do? How effective are they? | Remove particles from the air as small as 0.3 microns (Bacteria,fungi,viruses, dust( 99.97% effective |
| Where is the HEPA filter in C-SEC and BSC? | On top thus clean air flows down Vertical flow |
| Where is the HEPA filter in the LAFW? | In the back of the providing Horizontal airflow |
| Compounding should be done in the cleanest part of the LAFW/BSC/C-SEC which is where? | It is where the air is directly coming out of the HEPA filter called the direct compounding area |
| What is the Air from the HEPA filter called? | FIRST AIR |
| How often must the HEPA filter be recertified by a specialist? | Every 6 months and anytime a PEC has been moved |
| Most contamination of CSP comes from the employee himself from improper garbing and so forth. What must we do to all products we introduce to the BSC/LAFW? | Clean them 70% IPA (Isopropyl Alcohol) |
| How far must we work in the hoods to prevent exposure to ISO 7 air in the ISO 5 hoods? | Must work at least 6 inches in the hood |
| For Non-hazardous sterile compounding what kind of air pressure exists in the LAFW? | Positive pressure to protect the products from exposure/contaminates |
| For Hazardous Sterile compounding what kind of air pressure exists in the LAFW? | Negative pressure to protect the employee from exposure to the hazardous drugs |
| T/F The surfaces in a sterile room of floors, ceiling fixtures, shelving, counters and cabinets must be smooth and impervious and free from cracks to make them easy to clean and disinfect? | True |
| Most equipment to make it easier to clean and disinfect is made what kind of material? | Stainless steel (DO NOT BRING CARDBOARD BOXES INTO THE STERILE ROOMS) |
| What are the two types of sterile compounding areas? | Cleanroom suite Segregated compounding area (SCA) |
| What is a cleanroom suite? | Has one or more sterile hoods (ISO 5 PECs) inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom |
| What is a segregated compounding area (SCA)? | Has an ISO 5 PEC, sterile hood, often an isolate glovebox with a closed front located in a segregated space with unclassified air |
| What is a PEC? | It is a device or room that provides ISO 5 environment for sterile compounding |
| What is a laminar airflow workbench? How is the airflow? | Open front PEC (ISO 5) for compounding in sterile non-hazardous compounding Airflows horizontally out to prevent ISO 7 contaminants from flowing in |
| What is a Compounding Aseptic Isolator (CAI)? | Closed front PEC located in a buffer room but if often located in a segregated compounding area (SCA), since its closed prevents air from mixing and is usually called a glovebox, hands go through the gloves on front |
| What is the minimum garb requirement for CAI? | Must have hand hygiene and have streile powder free gloves to be used inside the CAI |
| What is the secondary engineering control (SEC)? | A room that contains the PEC commonly called the buffer area ISO 7 room with PEC with ISO 5 |
| What is the Anteroom? | Room that connects the rest of the pharmacy to the buffer room - contains the sink, cabinets, and benches to facilitated garbing and preparation for compounding. |
| What is the Line of demarcation in the anteroom? | Its the line that separates the room into clean and dirty sections, the area closest to the pharmacy is considered the dirty side of the anteroom |
| How do we apply shoe covers in the anteroom with the line of demarcation? | We put one cover on then place it past the line into the clean area, then apply the other to cross over into the clean side. |
| How does sterile compounding for emergencies differ than normal sterile compounding? | If we need stuff STAT sterility goes out the window at times so because of this whatever we compound in an emergency only has 1 hour BUD (Beyond use date) and must be discarded after 1 hour. |
| What is a SCA? | If a cleanroom is unable to be installed can use this, but it is an area with unclassified air aka no ISO level in the corner of a pharmacy no buffer area or anteroom can only be used for low risk CSPs |
| What is the BUD for something compounded in the SCA? | 12 hours max you can use product before tossing. |
| What can SCAs not be close to in the pharmacy? | Must be separated from food preparation, warehouses, construction sites, windows/doors, or pharmacy pickup areas. |
| What USP chapter sets the guidelines in handling hazardous drugs for compounding? | USP 800 |
| The USP 800 does what for hazardous drugs? | Tries to prevent toxicities to healtcare workers who handle them in any manner from compounding, administration, docking, stocking, and cleaning up body fluids, so to reduce exposure. |
| What institution determines if a drug is considered a hazardous drug? | NIOSH National Institute for Occupation Safety and Health. |
| What 5 things make a drug hazardous according to NIOSH? | 1. Carcinogenic 2. Teratogenic 3. Genotoxic (DNA damage) 4. Toxic to organs at low doses 5. Labelled as such by the manufacturer with special handling instructions |
| All chemotherapy drugs are hazardous drugs T/F Aka all antineoplastic drugs? | True |
| What is my 2 Abortifactant drugs that are Hazardous? | Mifepristone and Misoprostol |
| What is my one antibiotic that is Hazardous? | Chloramphenicol |
| What is my one Anticoagulant that is hazardous? | Warfarin |
| What is my 2 antifungals that are hazardous? | Fluconazole and Voriconazole |
| What are my 3 antiretrovirals that are hazardous? | Abacavir, Entecavir, Zidovudine |
| What are my 3 Antivirals that are hazardous? | Cidofovir, Ganciclovir, Valganciclovir |
| What is my Acne medication that is hazardous? | Isotretinoin |
| What is my AADs (Anti-arrhythmic) that is hazardous? | Dronedarone |
| What are my Autoimmune Drugs that are hazardous? | Acitretin, Azathioprine, Leflunomide, Fingolimod, Teriflunomide |
| What are my BPH medications that are hazardous? | Dutasteride, Finasteride |
| What are my Bisphosphonates that are hazardous? | Pamidronate, Zoledronic Acid |
| What are my Depression medications that are Hazardous? | Paroxetine |
| What are my Chemoprotectant drugs that are hazardous? | Dexrazoxane |
| What are my diabetes medications that are hazardous? | Exenatide, Liraglutide |
| What my dyslipidemia drugs that are hazardous? | Lomitapide |
| What Seizure medications are hazardous? | Clonazepam, Carbamazepine, Oxcarbazepine, Divalproex, Phenytoin, TOpiramate, Zonisamide, Vigabatrin, Fosphenytoin, ESlicarbazepine, Clobazam |
| What gout medication is hazardous? | Colchicine |
| What heart failure medication is hazardous? | Ivabradine Spironolactone |
| What hepatitis medication is hazardous? | Ribavirin |
| What hormonal agents are hazardous? | Androgens, Estrogens, Oxytocin, Progesterones, SERD/Serm (tamoxifen), Illipristal |
| What hyperthyroid medications are hazardous? | Methimazole, Propylthiouracil |
| What Insomnia medications are hazardous? | Temazepam, Triazolam |
| What irone overload medications are hazardous? | Dihydroergotamine |
| What Parkinson disease medications are hazardous? | Apomorphine Rasagiline |
| What Pulmonary Arterial Hypertension medications are Hazardous? | Bosentan, Ambrisentan, Macitentan, Riociguat |
| What Schizophrenia medication is hazardous? | Ziprasidone |
| What transplant medications are hazardous? | Cyclosporine Tacrolimus Sirolimus Mycophenolate |
| What are Safety data sheets? (SDS) | They are safety documents required by OSHA to be accessible to all employees handing hazardous materials and must provide drug specific safety information including PPE, spill clean up procedures, and first aid procedures |
| T/F Each facility must have a designated person who is responsible for making a SOP (Standard Operating procedures) focused on worker safety during all aspects of handling hazardous materials | True |
| What must a Hazard communication Program SOP Must include? | 1. Written plan for implementation of HD safety procedures, proper training, competency assessment, and maintaining all HD documentation |
| T/F Pharmacies must maintain a list of all hazardous drugs stocked | True |
| How often must the list of hazardous drugs be reviewed? | Every 12 months or when a new drug or dosage form is stocked or used |
| Before handling any hazardous drugs what must all men and women with reproductive capability do? | Must sign a waiver and confirm in writing that they understand the risks associated with handling HDs |
| T/F lowest risk activities for hazardous drugs avoid having to follow USP 800 if they have an assessment of risk (AOR)? | True |
| What are lower risk activities for hazardous drugs that avoid USP 800 regulations if they have AOR completed? | Counting and packaging of tablets |
| WHat 4 things must AoR SOP must include to limit staff exposure to HDs? | 1. Putting HDs onto distinctive shelves and bins to alert staff 2. Dedicated counting tray/spatula and cleaning them after 3. Placing prepared HD into sealable plastic bags 4. Wearing ASTM D6978 rated gloves when counting or packaging drugs |
| IF any manipulation of low risk hazardous drugs occurs we must follow USP 800 these include things like? | Using powder to make solution Cutting tablets in half Adding a vial of HD to a large volume fluid |
| If no AoR has been done for lower risk activities we must follow USP 800, AoR must be done when for lower risk activities? | Every 12 months |
| Any room or hood used for hazardous material compounding contain the word what? | Containment |
| Why do we use containment for HDs? | To keep HDs, particles, and vapors contained within the space due to toxicity risk |
| Where must non-sterile and sterile HDs be compounded in? | A C-PEC in either a C-SEC or C-SA |
| What are 3 types of C-PECs for hazardous drugs? | Biological safety cabinet Containment ventilated enclosures (CVE) Compounding aseptic containment isolators (CACI) |
| What are Biological safety Cabinets? | 1. They are vertical laminar airflow in which negative air pressure protects the worker from being exposed to the hazardous drugs they work with. |
| What class rating is the BSC for HDs? | Either Class II or Class III |
| What are Containment ventilated enclosures as a CPEC for HDs? | They are powder containment hoods with hepa filtered air and negative pressure only used for non-sterile HD compounding |
| What are Compounding Aseptic Containment Isolators (CACI) for HDs? | They are closed C-PEC (gloveboxes) that can be located in the buffer room but are often located in a C-SCA. |
| Typically we keep Non-Sterile HD away from Sterile HD preparation what are the exceptions to this? | 1. Must contain all the follaowing : - C-SEC must maintain ISO 7 even for non-sterile HD, Non-sterile C-PEC and Sterile C-PEC must be 1 meter apart Cannot work on Powders when any sterile compounding is being performed in the same C-SEC |
| T/F C-PECs C-SECs adnd C-SCAs all have negative air pressure to protected the workers? | True |
| What are the Air change requirements for Non-Sterile HD prep? For sterile C-SEC? For C-SCA? | 1. 12 ACPH (Air Changes Per hour) 2. 30 ACPH 3. 12 ACPH |
| Do Containment rooms need external exhaust? | Yes HDs will be externally exhausted from the C-PEC, C-SEC, or from non-sterile HD, the air cannot be recirculated |
| What is an alternative option to external exhaust where its not allowed for some places for non-sterile HD preparation only? | Redundant HEPA filters in which it goes through 2 filters |
| How must we store HDs? | Must be stored separately from non-hazardous drugs in an externally ventilated room which has negative pressure with at least 12 ACPH (Air changes per hour) |
| Personnel need training for Compounding what is initial training? | -Didactic training (lectures/vids/teaching) and hands on training which must be observed by the designated person in charge of compounding |
| What is continuous training (ongoing) for compoaunding? | Training when updated procedures are created, new drugs, revised drug information, or new equipment |
| What are the 4 Required training and testing for sterile compounding? | 1. Hand Hygiene 2. Garbing and gloving technique 3. Cleaning and disinfecting procedures for space and equipment 4. Sterile drug preparation |
| How do we test adequate hand hygiene, garbing, and gloving? | The Glove Fingertip test |
| How do we test aseptic technique for proper drug preparation? | Media Fill Test |
| How often must we pass the glove fingertip test/media fill test if working with low end and medium risk CSPs? High risk CSPs? | Initial test then yearly for low/medium risk CSPs Semi-annually for high risk CSPs |
| How does the Glove fingertip test work? | After garbing the evaluator rolls the fingers and thumb over a surface that has Tryptic Soy Agar - the plates are then intubated for 2-3 days and look for microbial growth - if spots are seen its contaminated called Colony forming units (CFUs) |
| How many times do we have to pass a glove fingertip test? | For initial test must pass 3 consecutive glove fingertip tests with zero CFUs on both hands Ongoing annually - one sample from each hand after completion of the media fill test with a goal of <3 CFUs total for both hands |
| Media fill tests show if you can do aseptic technique when preparing CSPs how does it work? | We have tryptic soy broth in the bags then doing transfers into the bag, if after 14 days no growth you pass. If there is turbidity (cloudiness) then you failed |
| Temperature for the SEC room must be checked how often and be at what temperature? | Once daily checked Temp 20*C (68*F) |
| Temperature for the refrigerator and freezer are monitored daily unless they have contain vaccines which means twice daily. What temperatures should they be? | Refrigerator - 2-8*C Freezer -25 to -10*C UNLESS THERE IS VACCINES USP 797 it needs to be -50 to -15*C |
| What are some tests that need to be completed to test the environment of the Compounding room and how often should they be done? | 1. Air quality sampling Q6 Months 2. Surface samples of most touched surfaces at end of day 3. Air pressure testing - once daily or with every work shift (+/- pressure) 4. Humidity testing - once daily |
| What should the humidity be held at in compounding rooms? | <60% humidity |
| How often should PECs and CPECs be run? | Should be run 24/7 |
| If there is a power outage and PEC and CPECs stop working we must stop compounding immediately but what do we do to resume when power is back? | Must clean all PECs with germicidal detergent and then disinfected with 70% Isopropyl Alcohol (IPA) prior to re-initiation Must also be turned on for 30 minutes running before starting again |
| What kind of wipes need to be used to clean the PECs? | Lint free sterile wipes |
| What is the motion to properly clean PECs? | Slightly overlapping unidirectional strokes rather than circular strokes Top to bottom and back to front aka the cleanest parts to the dirtiest parts |
| What areas of the compounding room must be cleaned monthly? | Ceiling Walls Shelving Chairs Bins Carts |
| ISO 5 PECs should be cleaned how often? | 1. Before each shift 2. Every 30 minutes 3. Before and after each batch of CSPs 4. Whenever needed especially after spills |
| T/F Counters and floors must be cleaned daily while outside materials must be cleaned before entering the compounding room? | True |
| How do we clean for hazardous drugs in the compounding room? | 1. Deactivation/Decontamination - reduce HD toxicaity and remove HD residues 2. Then Cleaning - Gets rid of dirt and microbes 3. Then disinfection - Destroys microorganisms |
| How do we deactivate and decontaminate for HDs? | 2% Bleach (Sodium Hypochlorite) or Peroxide |
| How do we clean for HDs? | Germicidal detergent such as Quat, Ammonium, Phenolics |
| How do we Disinfect for HDs? | 70% IPA using |
| Should we use Sprays or wetted wipes for HDs cleaning? | Wetted wipes |
| T/F If we are cleaning for hazardous drugs we should wear all required PPE? | True |
| Bleach being used for deactivation and decontamination can cause corrosion of the stainless steel how do we prevent corrosion? | Immediately after using bleach, we must neutralize it with sodium thiosulfate, sterile water, sterile alcohol or with a germicidal detergent |
| How often do we do surface sampling for HD areas? | Initial then every 6 months to ensure hazardous residue is adequately contained. |
| If exposed to drugs what must employee do? | Get the drug or chemical off the person as fast as possible |
| What are the minimal protocols to follow if exposed to chemicals/drugs? 5 things | 1. If exposed on gloves/gown - remove the garb that has drug on it 2. Immediately clean skin with soap/water 3. For eye exposure eyewash station 15 min 4. Obtain medical attention if warranted 5. Document exposure in employees record |
| When must eye and face protection be work for HD? | Must always be worn if there is a risk for HD spills or splashes even if working inside a PEC or administering outside PEC |
| What is the most preferred eye face protection? | Goggles for eye protection in combination with face shields |
| When should we have respiratory protection for HDs? | HDs that are unpacked and are not contained in plastic patients should wear an elastomeric half mask with a multi-gas cartridge and P100 filter |
| What type of mask is sufficient for most HD compounding ? | N95 Mask |
| What types of situations if N95 Mask not good enough for HD compounding? | 1. Spills that require more stuff 2. Deactivating/decontaminating under the C-PEC 3. If Airborne exposure to HD powders/vapors 4. Disposal of PPE used when handling HDs |
| In those rare circumstances a N95 mask is not good enough and there is a risk of respiratory exposure what should be worn 2 options? | 1. A fit tested respiratory mask with a gas canisters 2. A powered air purifying respirator PAPR |
| What gives guidance on how to clean hazardous drug spills? | The safety data sheet (SDS) |
| When a spill happens with HDs what do we do? | 1. Who = who responds and who needs help if exposure 2. What - the rapid assessment to determine what is needed 3. When - refers to the need to clean up spill immediately |
| How to manage spills? | 1. Spill kits accessible 2. Quickly limit access to area 3. Warning sign Caution: Hazardous spill proceed with caution |
| What is included in a spill kit? | 1. Protective gown, latex gloves, N95, Goggles 2. HD waste bag - chemo pads to absorb, scoops/scraper to remove and place in bag 3. HD spill report exposure form |
| How do we dispose of spill waste? | Dispose into bulk hazardous waste into the black bulk hazardous waste bin |
| After spill is cleaned what do we do? | Doff (remove) garb and perform hand hygiene Decontaminate the respirator and replace cartridges Replace spill kit |
| T/F Appropriate PPE must be worn when administerin HDs aka two pairs of chemotherapy gloves are required for all HDs and A chemotherapy Gown if administering IV HDs? | True |
| What is a Closed-System Drug transfer Device (CSTDs)? | They are vial transfer systems offering more protection against exposure and must be used by nurses for drug administration, to reduce leaks and spills when withdrawing solutions from vials and injecting into IV bags |
| What are chemotherapy pins used for during administration? | They prevent HDs from aerosolizing by reducing the air pressure with venting |
| T/F CSTDs are recommended when compounding HDs and are required for administering antineoplastics? | True |
| If we must manipulate a solid tablet HD (aka we prefer not to) what do we need to do? | Crush tablets in a plastic bag to contain any dust or particles |
| When disposing of PPE what goes in the yellow bucket? | Trace HD waste like syringes, IV bags, Used PPE including gowns, gloves, masks, and shoe covers |
| What is for disposal in black bucket? | Any containers that contain a clear visible amount of HD and any supplies used to administer HDs or to clean up HD spills. (Drug vials/IV bags) = BULK HD waste |
| Can Pneumatic tube systems be used to transport any liquid HDs or any antineoplastic? | No because they could break then lead to contamination of the whole pneumatic tube system |
| For cleaning up spills or compounding HDs what kind of gloves must be work for HDs? For receiving and storage of HDs? | Double ASTM D6978 Chemotherapy gloves for spills/compounding Single ASTM gloves for receiving and transport |
| When compounding Non-Sterile Hazardous drugs what must be down? | Double gloves, A gown, and a mask and a disposable pad to protect the work surface |
| For sterile Hazardous drug compounding what must be worn? | Head Cover Face Mask Beard Cover Two pairs of shoe covers A gown impermeable to liquids Two pairs of ASTM gloves Full facepiece respiratory or face shield with gloves |
| What must be removed when entering the ante-area? | Must remove Coats, Sweaters, Makeup and visible jewelry |
| Can we have artificial long nails for sterile compounding? | No we cannot |
| What is the proper order to garb for Sterile compounding? | Head and facial hair covers, then face mask, then 1 shoe cover at a time stepping over the line of demarcation, then wash hands with soap warm water, clean under nails, work from fingertips to elbows in circular motion and dry with lint free towel |
| If compounding HDs how many shoe covers? ASTM gloves? | two shoe covers two ASTM gloves |
| After washing our hands what do we do? | Don a non-shedding disposable gown, enter buffer area apply alcohol based surgical hand scrub, then put on sterile powder free gloves (if HD use two ASTM gloves), then sanitize gloves with 70 IPA routinely |
| What is proper garbing for HDs for respiration? | -Fit tested N95 mask for most compounding -Surgical respiratory -Elastomeric half mas with gas cartirage if unpacking HDs not in plastic wrap -PAPR - for cleaning spills or cleaning under C-PEC or if their is suspected airborne exposure |
| How often must ASTM gloves be changed for HD compounding? For normal sterile compounding? | 1. Every 30 minutes for HD 2. One pair is fine for low risk |
| If the HDs are lower risk how many gloves is acceptable? | One pair of gloves |
| How do we wear the two gloves for ASTM for HDs? | One pair of ASTM under the cuffs of the gown One pair of ASTM over the cuffs of the gown |
| When do we need to wear eye/face protection for HDs? | WHen there is risk for HD spills/splashes when working outside of a C-PEC |
| What do we wear for Eye/face protection for HDs? | Full-facepiece respirator or face shield with goggles is acceptable |
| T/F The gown for HDs must be disposable and not renewable, but for other sterile drugs it can be reusable if washed | True cannot be re-used |
| What kind of Gown must be worn for HD compounding? | Ones that are impermeable made of polyethylene coated polyporpylene or other laminate material |
| How often do we need to change a disposable gown for HD compounding? | Every 2-3 hours |
| Besides alcohol washing our hands what else can we use before putting on gloves? | Chlorhexidine or povidone-iodine (Betadine) |
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