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Naplex
Compounding
| Question | Answer |
|---|---|
| What balance is used for nonsterile compounding | - Torsion: accepted error rate 5%, sensitive requirement 6mg, minimum weight quantity 120mg; using forceps (pincers) to handle external weight. External weight is placed on the right - Electric: NOT require MWQ |
| Volume measuring | Cylindrical and conical (hình nón) graduates Syringes Pipettes and droppers |
| Mortars and pestles | grind substance into a finer consistency |
| Glass mortars | for liquid or mixing compounds that are oily or can stain |
| Porcelain mortars | has smooth surface , used for blending powders and pulverizing (nghiền nát) gummy consistency |
| Wedgwood mortars | has rough surface, used for grinding dry crystals and hard powders |
| Rubber spatula | is used for Corrosive material |
| Steel spatula | Not for metalic ions |
| Powder sieve | cái rây , for seperating larger particle and ensuring uniform particle |
| ointment slabs | |
| disposable parchment ointment pads | |
| mold | khuôn |
| capsule with hard shells | making from gelatin, pork - derived, or hypromellose or a similar plant derived product |
| Active pharmaceutical ingredient (API) | USP national formulary (USP NF) and from FDA registered facility |
| Missing expired date of materials for compounding | Assigned 3 yrs from the date of receiving the item |
| Surfactant is amphiphilic (Lưỡng thân) | Hydrophilic and hydrophobic (Ưa nước và kỵ nước) |
| Wetting agents / Levigating agent | reduce surface tension btw liquid and solid |
| Levigation | Grind particles w a small amount of liquid (wetting agent) in which the powder is insoluble. - Mineral oil: Levigating agent for lipophilic compound - Glycerin / propylene glycol for aqueous compound |
| dispersant (Chất phân tán) | suspending agents |
| Plasticizer | make the preparation easier to shape or mold. Eg: Sorbitol for gelatin capsule |
| Ora plus | gel-like structure, slightly acidicic to reduce drug degradation via oxydation. Bland taste |
| Ora sweet | Provide flavor to ora plus |
| Ora Blend SF | Sugar free, alcohol free |
| Simethicone | Anti-foaming agent |
| Emulsifier (Liquid in liquid) | Keep the droplets dispersed (phân tán) in the liquid vehicle |
| Lower HLB # | More Lipid Soluble (water/oil) |
| Higher HLB # | More H2O Soluble (oil/water). |
| hydrophilic-lipophilic balance - HLB mid point | 10 |
| Binder | Allow the contents of a table stick together, to provide stability and strength. Also allow the content released once ingested. Acacia, Starch paste, Sucrose syrup, compressible sugar (Nu-Tab) |
| Dilute / filler | - Tab / cap: Sugar (lactose, manitol, sorbitol), starches, calcium salt, cellulose powder - Liquid: water, glycerin, alcohol - Topical: Petrolatum, mineral oil, lanolin |
| Disintegrant | Alginic acid, cellulose, starches |
| Sweeteners | - non caloric, artifical: Aspartame, Saccharin, Scuralose - Glycerin - Dextrose - Sugar alcohol: mannitol, sorbitol, xylitol - Stevia |
| coloring | - D&C Red N.3 - Yellow No. 6 - Caramel - Ferric oxide (red) |
| Lubricant - prevent sticking, improving flowability | - Mg stearate, calcium stearate, stearic acid - Peg - Glycerin - Mineral oil Talc |
| Preservatives | - |
| Trituration | Grind into a fine powder |
| Levigation | Just like trituration, but with a levigating agent |
| COMMINUTION | Trituration Levigation |
| Water activity (Aw) | Available water in a compound |
| The higher the Aw, | The more water,increase Risk of microbial growth or degradation, Shorter BUD |
| AW >= 0.6 | Aqueous |
| BUD for Aqueous formulations (Aw ≥ 0.6), Oral | 14 days, Store in refrigerator |
| BUD for Aqueous formulations (Aw ≥ 0.6), Topical Nonpreservative | 14 days, Store in refrigerator |
| BUD for Aqueous formulations (Aw ≥ 0.6), Preservative | 35 days |
| BUD for Nonaqueous formulations (Aw < 0.6), Oral liquids | 90 days |
| BUD for Nonaqueous formulations (Aw < 0.6), Others | 180 days (6 months) |
| Ointment vs cream vs lotion for water content | - Oitment: 0-20% - Cream: 20-50% - Contain the most water |
| What excipients avoided in children | - Alcohol (hypoglycemia, acidosis, CNS depression) - Preservatives for neonate |
| Avoid sugar alcohol (mannitol, sorbitol, xylitol) if | - IBS (cause GI destress) - Xylitol avoid for dog (hypoglycemia and hepatoxicity) |
| Avoid sucrose (sweetener, coating) if | DM |
| Avoid lactose if | - Intolerance or allergy |
| Avoid glutin if | - Celiac disease |
| Avoid Aspartame (contain phenylalanine) if | Phenylketonurea (PKU): can't metabolize phenylalanine |
| Avoid gelatin from animal if | Vege |
| Spatulation | Similar to levigation, but on oitnment slab w a spatula |
| Pulverization | for crystallize powder: dissolved in solvent and mix until solvent evaporates. |
| Geometric dillution | - 2 small amount is mixed, repeated. Applied for |
| Eutectic mixture | Occurs when two solids are mixed and liquefy (or become soft/wet) at a temperature lower than the melting point of either component alone. |
| Meting point order | Melt the highest melting point first |
| oleaginous base | nền dầu |
| BUD for unit dose repacking | Manufacturer expiration or 6 mos from the repacking date |
| Master formulation record | recipe. What you should do |
| Compounding record | log book for all compounding What you DID |
| PEC (primary engineering control) - sterile hood | Horizontal LAFW (PEC) - ISO-5 air. |
| Horizontal | Air comes from the back of the hood Positive air pressure |
| HEPA filters | PEC pushes 1st air to DCA (direct compound area) First air - the cleanest |
| work should occur at least | six inches from the front and back of the PEC |
| SEC = buffer room | - secondary engineering control: PEC is located inside - contains ISO-7 air & positive air pressure. |
| Sterile compounding buffer room ACPH | 30 air changes per hour |
| anteroom for non-hazadous sterile compounding | ISO-8 air |
| anteroom | don garb and wash their hands. |
| Hazadous (sterile or non-sterile) | inside C-PEC (containment) |
| BSC | Biological safety cabinet |
| CACl | Compounding Aseptic Containment Isolator |
| C-SEC - АСРН | ≥ 12 for non-sterile compounds ≥ 30 for sterile compounds |
| SEC 797 - АСРН | 30 |
| Anteroom 797 - АСРН | 20 |
| Irrigation - Liquid wash of a body cavity | CSP - Compounded sterile product |
| Cleaning schedule for Non-sterile compounding areas | - Working surface: beginning and end each shift, after spills, between making compounds from different components - Floor: daily , after spills - Walls & Storage shelves: 3 mos |
| Cleaning schedule for Sterile compounding areas | - Daily: PEC, Floor - Monthly: Wall, doors, ceiling, shelves, pin, etc |
| Hood / PEC - Air direction / flow | - NON-Hazardous: Horizontal - Hazardous : Vertical |
| Air pressure - SEC | - NON-Hazardous: Positive - Hazardous : Negative |
| ISO air requirement for Anteroom for sterile compouding | - NON-Hazardous: ISO 7 or 8 - Hazardous : ISO 7 MUST |
| Segregated Compounding Area (SCA) | • Alternative to a standard "cleanroom" • Designated area with unclassified air • Beyond-use date (BUD): 12 hours if at room temperature; 24 hours if refrigerated |
| C-SCA ACPH | 12 air changes per hour |
| USP 797: ? CSP Risk Categories - IF Preparation Environment: Uncontrolled | - Immediate-use - Refrigerated, BUD: 4 hours |
| USP 797: ? CSP Risk Categories - IF Preparation Environment: ISO 5 PE in an SCA | - Category 1 - Room Temp BUD: 12h - Refrigerated BUD: 24h |
| USP 797: ? CSP Risk Categories - IF Preparation Environment: ISO 5 PEC in a cleanroom | - Category 2 - Room Temp BUD: 1-45 days - Refrigerated BUD: 4-60 days - Frozen BUD: 45-90 days |
| USP 797: ? CSP Risk Categories - IF Preparation Environment: ISO 5 PEC in a cleanroom | - Category 3 - Room Temp BUD: 60-90 days - Refrigerated BUD: 90-120 days - Frozen BUD: 120-180 days |
| Garbing for NON-Sterile Compounding | Gloves |
| Garbing for Sterile Compounding | - Remove accessories - Don head and shoe covers - Wash hands - Don gown - Don sterile gloves |
| Hazardous compounding | - 02 pairs of chemotherapy gloves - 02 pairs of shoe covers - 01 chemotherapy gown. |
| CSP: Staff Training - Gloved fingertip test | - If personnel garb appropriately. - Zero colony -forming units are permitted on initial training - 3 or less are required upon continuous training |
| CSP: Staff Training - Media-fill test | If personnel compound with aseptic technique. - Passed if the bag must remain clear of bacteria - Fail if the bag is cloudy |
| Compounding Waste - BLACK | Bulk HD waste: Unused IV bags of hazardous drugs, or supplies used to clean up after a hazardous drug spill, such as towels or PPE |
| Compounding Waste - YELLOW | Trace HD waste: Empty, but used syringes, and PPE used for hazardous drug compounding or administration that is not obviously contaminated |
| Compounding Waste - RED | NONhazardous sharps: needles used for non-hazardous drug compounding as well as infectious waste |
| how long for hand wash in anteroom | at least 30 seconds |
| How frequently to change gloves for hazardous compoundings | -Every 30 mins and additional times if torn, punctured or contaminated. - After donning the initial pair, the gloves need to be changed 23 more times within the 12-hour shift. |
| How frequently to change gown for hazardous compoundings | - Manufacturer's schedule - Every 2-3 hrs and immediately after a spill or splash. - A minimum of 4 gowns will be needed during a shift of 12 hrs. |
| BUD for for Single Dose Containers - ISO 5 environment | - Up to 12 hrs from opening |
| BUD for for Single Dose Containers (ampule) - w or w/o ISO 5 environment | - Must be discarded |
| BUD for for Multi Dose Containers - w or w/o ISO 5 environment | - Up to 28 days from opening |
| Hazardous definition | - Carcinogenic - Teratogenic - Toxic to reproduction (infertility) - Genotoxic - Toxic to organ (lower dose) |
| Chemotherapy | Hazardous |
| What anticoagulant is Hazardous | warfarin |
| What antiviral are Hazardous | - Cidofovir - Ganciclovir - Valganciclovir |
| What benzodiazepine are Hazardous | - Clonazepam - Temazepam |
| What antiseizure are Hazardous | - Carbamazepine - Oxcarbazepine - Phenytoin / Fosphenytoim - Topiramate - Valproate |
| What DM is Hazardous | Exenatide |
| What Dyslipidemia is Hazardous | Lomitapide (Juxtapid) |
| What HF med is Hazardous | Spirinolactone |
| What PAH is Hazardous | - Ambrisentan - Bosentan - Macitentan - Riociguat |
| What SSRIs is Hazardous | Paroxetine |
| What THIONAMIDS are Hazardous | - Methimazole - Propylthiouracil |
| What tranplants med are Hazardous | - Cyclosporine - Mycophemolate - Tacrolimus - Sirolimus |
| What AUTOIMMUNE are Hazardous | - Acitretin - Azathioprine - Fingolimod - Leflunomide - Teriflunomide |
| What Hormone are Hazardous | - Testosterone - Estrogens (estradiol) - Oxytocin - Progestins (Medroxyprogesterone) - SERD / SERMs (fulvestran, raloxifene, tamoxifen) - Ulipistal |
| What BPH are Hazardous | - Dutasteride - Finasteride |
| Where to prepare NON-sterile hazardous compounds | C-PEC located in C-SEC or C-SCA |
| Minimal distance from sterile and nonsterile C-PEC if both located in the same C-SEC | 1 meter |
| BUD for Triestrogen capsules (Aw = 0.44) | 180 days = 6 mos |
| BUD for a PO liquid (Aw = 0.44) | 90 days = 3 mos (applied ONLY for liquid) |
| palatability | độ ngon miệng |
| poloxamer lecithin organogel (PLO) | - Common gelling agent |
| the dissolved cetylpyridinium powder | wetting agent |
| Sorbitol | - Sugar alcohol - flavor agent - Avoid in patients with IBS (alternative is glycerin) - Plasticizer for gelatin capsules |
| xanthan gum | thickening agent - increase the viscosity Other: agar, starches, bentonite, and gelatins. |
| ascorbic acid and lecithin | Antioxidant - prevent oxidative damage |
| When to y require use of a filter needle? | Transferring solutions from an ampule (glass container) |
| Closed-system transfer device - CSTD | - Compounding with hazardous drugs: prevent leaks and spills by containing all liquid in the device while withdrawing from a vial. - Administering anti-neoplastics. |
| Surface test | Performed on equipment used to compound sterile products |
| Poloxamers (Emollients / Moisturizers) | - Poloxamers are gel at room temperature but liquid when refrigerated - It is thermoreversible. - Poloxamers contain a hydrophobic chain plus 2 hydrophilic chains - It is commonly used for compounding transdermal products. |
| Lactose | diluent / filler agent |
| The water bath | To protect ingredients from overheating and burning. |
| Aspartame | A non-caloric, artificial sweetener. |
| glycerin | Levigating agent |
| Dry gum method | 1. Levigate the gum with oil. 2. Add water all at once. 3. Triturate until a cracking sound is heard and the mixture looks creamy white. 4. Add other ingredients and water sufficient to make the final volume. 5. Homogenize the emulsion. |
| What groves for hazardous | Two pairs of ASTM-rated gloves |
| petrolatum | Emollient for ointment |
| What tool is used to measure glycerin | Syringe (for viscous (thick) liquids) |
| what Magnesium salt is used as a lubricant? | Magnesium stearate |
| Capsule size number | The SMALLER the number, the LARGER the capsule. |
| Benzoic acid | Preservative |
| Sucralose | - A non-caloric, artificial sweetener used to increase the palatability of compounded oral formulations |
| Xanthan gum | Thickening agents increase the viscosity of a substance and can provide stability to the mixture. |
| PLO gel | Pluronic lecithin organogel (PLO) gel is a transdermal vehicle used by compounding pharmacists to administer medications through the skin. |
| Eutectic | When the melting point is lower, the drug will penetrate the skin more efficiently. Eutectic mixtures have a lower melting point, thus better penetration than any of the components alone. |
| A base of sucrose or syrup (sugars) can be used to prepare | Hard lozenges |
| Hydrophilic solvents | - Distilled water - Benzyl alcohol - Polyethylene glycol |
| What agent reduces the surface tension between two liquids? | Emulsifier |
| Theobroma oil | Cocoa butter - suppository bases but often newer bases are selected because theobroma oil melts easily |
| Sodium lauryl sulfate | Surfactant - usually selected for soap or shampoo - It is an excipient often used when working with powders that acts as a surfactant and neutralizes static charge (to keep the powder from floating away. |
| sieves | sifter - is to ensure a uniform particle size |
| ? Density factor | Indicates the amount of base that will be displaced by the drug. This is an important factor when compounding suppositories |
| Wet gum method | |
| Examples of ointments | Aquaphor, Aquabase, Polybase and petrolatum |
| Tincture | Dung dịch chiết (bằng cồn) |
| Types of solutions | Syrups, tinctures, elixirs and spirits |
| Fusion molding method | - Ingredients are poured into room tem molds. - Lubricants should be the opposite of the suppository base in terms of solubility. A water-soluble lubricant, such as glycerin or propylene glycol, would be a good choice for this oil-soluble suppository. |
| Oil-soluble suppository lubricant? | Glycerin or propylene glycol |
| Filtration sterilization | Heat-labile (kém bền với nhiệt) CSPs |
| Bubble-point test | Is used when sterilizing with filtration. The bubble-point test uses a 0.22 micron filter. |
| HEPA filter | 99.97% of particles ≥ 0.3 microns |
| ISO (≥ 0.5 um) | - ISO 5: 3,520 - IS07: 352,000 - ISO 8: 3,520,000 |
| How often should a laminar airflow workbench be cleaned when making compounded sterile products (CSPs)? | - Be cleaned at the beginning of each shift, - Before and after each batch of CSPs - Every 30 minutes while working. PECs should also be cleaned after spills and any time contamination is suspected. |
| Cleaning of a horizontal laminar airflow workbench | Cleaning and disinfection of the hood with 70% isopropyl alcohol must be done in an overlapping linear motion, from top to bottom and back to front. |
| Steam sterilization - autoclave: avoid if | - Protein-based drugs: insulin and hormones (human chorionic gonadotropin, levothyroxine) |
| TRUE or FALSE: The hood must be turned off any time it is not being used for compounding activity. | FALSE |
| testing of the surfaces involved in sterile compounding | - Every 30 days and at the end of the compounding shift. - Surfaces regularly exposed to staff should be tested. - Action must be taken if > 3 CFUs in ISO 5 area, > 5 CFUs in the ISO 7 area or > 100 CFUs in an ISO 8 area. |
| Laminar airflow in a sterile compounding hood describes airflow that is: | Unidirectional (Một chiều) |
| Initial gloved fingertip test | - At least three consecutive samples from both hands, with zero CFUs for both hands |
| For a compounder to pass the media-fill test, how long must the sample remain free from turbidity (Độ đục)? | Turbidity on or before day 14 indicates that contamination is present. If the liquid stays clear after 14 days of incubation, the compounder passed the test. |
| Endotoxins | Endotoxins from Gram-negative bacteria are more potent and represent a serious threat to patient safety. |
| Which agent is used to clean sterile hoods and gloved hands during compounding? | 70% isopropyl alcohol |
| How often must the HEPA filter in a primary engineering control be recertified by a specialist? | HEPA filters should be recertified every 6 months or anytime a primary engineering control has been moved |
| A pharmacy technician is compounding cefazolin 2 g in 50 mL of D5W for intravenous infusion. How should the pharmacist verify that the correct volume of ingredients was used in the preparation? | Direct visualization of the syringe before compounding |
| Clean hands with an alcohol-based surgical hand rub THEN Don gloves | |
| To decontaminate surface areas that have been exposed to hazardous drugs. | Sodium hypochlorite (bleach) is used commonly |
| How often should the pharmacist-in-charge perform a wipe sampling to determine the amount of hazardous drug residue in the class II biological safety cabinet? | initially as a benchmark and at least every 6 months |
| A hazardous drug spill kit DOESN'T contain | Broom and dustpan to get spill waste into HD waste bag (Chổi và hốt rác để thu gom rác thải bị rơi vãi vào túi đựng rác loại HD.) |
| order of steps to be taken for daily sanitization of sterile hazardous compounding areas? | Deactivation, decontamination, cleaning, disinfection |
| Elastomeric half mask with a multi gas cartridge and P100-filter | Be used when unpacking HDs not wrapped in plastic until an assessment of the packaging ensures that no breakage or spillage occurred during transport. |
| ACPH for non-sterile HD | In a space where non-sterile hazardous drugs are compounded, a minimum of 12 ACPH are required. |
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