Identify and assess the importance of critical sites in sterile product compounding.docx

EXAM 2: Identify and assess the importance of critical sites in sterile product compounding Hub of needle Shaft of needle Hub of syringe Exposed syringe plunger Rubber stopper of vials Ports of IV bags Establish appropriate aseptic technique, taking into consideration airflow direction, reconstituti...

EXAM 2: Identify and assess the importance of critical sites in sterile product compounding Hub of needle Shaft of needle Hub of syringe Exposed syringe plunger Rubber stopper of vials Ports of IV bags Establish appropriate aseptic technique, taking into consideration airflow direction, reconstitution of vials and appropriate distance within the hood Usually exchange ~2 mL at a time for small vials Work 6 inches from edge Do not block airflow Correctly space items in hood, 2 finger-widths apart Do not touch hub or plunger of syringe Determine the correct dosage and rate of compounded sterile products and prepare a label accordingly Describe the scope and components of UPS Chapter <797> UPS Chapter <797> is Sterile Compounding Scope: Sterile compounding Category 1: Lease controlled environmental conditions Room Temp (20-25): BUD 12 horus Refrigerated (2-8): BUD 24 hours Category 2: More environmental controls than category 1 BUD: Category 3: Highest level of environmental controls Immediate Use CSPs Not subject to the requirements for Category 1,2, or 3 CSPs when all the following are met: Processes are in place to minimize contact with nonsterile surfaces, conventionally manufactured products or CSPs Prepared according to drug labeling Preparation involves not more than 3 different sterile products Any unused starting component is discarded after preparation Administration begins within 4 hours from start of preparation Must be labeled with names, amount of ingredients unless administration is performed by person who compounded Single and multi dose CSPs Single-dose vials: If vial entered in ISO 5 or cleaner, may be used up to 12 hours Ampuls may not be reused Multi-dose vials: Designed to contain more than oen dose and can be entered multiple times Contain preservative to inhibit growth of microorganisms After initial enter, BUD for 28 days Garbing requirements; Lint-low gown with sleeves that fit snugly around wrists with an enclosed neck Low-lint shoe covers Low-lint head covering that covers all hairs and ears Facial hair cover Sterile power-free gloves Sterile 70% isopropyl alcohol applied to gloves before entering the compounding area and regularly throughout compounding ISO Class Particle Count per Cubic Meter 3 35.2 4 352 5 3,520 6 35,200 7 352,000 8 3,520,000 Air Quality Requirements: ISO Class 8: Anteroom with access to positive-pressure buffer room ISO Class 7: Anteroom with access to negative-pressure buffer room ISO Class 7: Buffer room ISP Class 5: Preparation of Class 1, 2, 3, CSPs Cleaning: Cleaning agent: used for removal of residues such as dirt, debris, residual drug from surfaces Disinfectant: used on surfaces and objects to destroy fungi, viruses, and bacteria Sporicidal agent: destroys bacterial and fungi spores when used to a specific concentration for a specified contact time Parenteral Drug Administration: Recommend appropriate needle gauge for various administration routes Smaller the number, larger the gauge (inside diameter) Ranges from 27 (finest) to 13 (largest) Ex: IM injection if 22-25 gauge Blood donation is 18 gauge Length is measured in inches from hub/shaft juncture to the tip of needle point Ranges from 3/8 to 3 ½ inches Route: Muscle, IM; Subcu tissue, SubQ (45) ; IV (25); ID (10) Review plastic and glass IV infusion containers and tubing IV infusion: Glass: Does not collapse as fluid exits, requires vented tubing Soft plastic: Most common plastic is PVC, collapses as fluid exits; doesn’t require vented tubing Hard plastic: Polyolefin, no plasticizers Does not collapse, requires venting Tubing: PVC with DEHP: Most common, soft, not compatible with some medications PVC: For lipids and drugs incompatible with DEHP Non-PVC lined: Inner lume lined with non-PVC materials Non-PVC: More rigid, doesn’t work with infusion pumps Discern between peripheral and central lines Peripheral IV Access: Catheter tip terminates in peripheral vein Peripheral catheters Midline peripheral catheters Vein Location: Metacarpal, cephalic, basilic, accessory cephalic, upper cephalic Replace every 72-96 hours (infection risk), temporary medication admin Central IV Access: Peripherally-inserted central catheter (PICC) Non-tunneled catheter (short-term) Subcutaneous tunneled (long-term): Broviac, Hickman Implanted vascular access: Port Can remain in place for 2-6 weeks (reliable IV access, critically ill or long-term); good for medicaitions that may harm peripheral veins Discern between primary and secondary (piggyback) lines Primary: connects IV fluid to patient access point Secondary: connects IV fluid to primary line, creating a Y side Understand the anatomy of an IV administration set Recognize common IV fluids 0.9% Sodium Chloride – Normal Saline (NS) 0.45% Sodium Chloride – Half-Normal Saline (Half NS) Dextrose 5% in Water (D5W, D5) Dextrose 10% in Water (D10W, D10) Lactated Ringers (Sodium, Potassium, Calcium, Chloride, Lactate) – LR Dextrose 5%/0.45% Sodium Chloride + 20 mEq KCl Review the use of flushes and locks Access catheter function, maintain patency, prevent contact between incompatible medications Frequency depends on device; locks (heparin) prevent blood clots from forming SASH: Saline (make sure line is working) Admnistration of drug Another saline flush to remove med left in the line Heparin lock to prevent blood clots from forming Drug product substitution: Orange Book FDA legislation 1906: Pure food and Drug act (established FDA) 1938: Federal Food, Drug and Cosmetic Act Products must be safe and pure; required to submit NDA 1962: Kefauver-Harris Amendments Products must be safe and effective; required to conduct clinical trials 1984: Hatch-Waxman Act Drug price competition and patent term restoration act 2009: Biologics price competition and innovation Act State Laws: In Iowa: pharmacy may request substitution of a lower priced generic and TE drug for a higher priced prescribed drug Pharmacy shall obtain the approval of the provider prior to requesting subs Pharmacy shall not subs an equivalent drug contrary to a prescription drug order that prohibits a subs. Brand name vs. Generic products Therapeutic equivalency Pharmaceutical equivalence: Same drug, dosage form, route of admin, strength Bioequivalence Cmax (tmax) and AUC FDA’s bioequivalence range 80-125% Pharmaceutical equivalency Work the same, generic must meet high standard to get FDA approval, approved generics are only sold after patents and exclusivities protecting the brand-name version end Generics cost less Drug product substitution Why generic prescription substitution? Cheaper price, cost saving Generic subs may not be appropriate for all drugs: hormones, drugs with Critical Dose (CD) and Narrow therapeutic ratio (NTR) FDA’s approval processes (NDA and ANDA) Orange Book List of approved drug products with TE evals based on safety and efficacy Helps identify multisource products: products that are available in more than one TE products Determine products that are therapeutically equivalent (TE) to each other TE codes Assists generic company in identifying reference products: “RLD” & “RS” If test product and RLD/RS are TE (PE + BE), then: Get an “AB” code; “A_” if TE products, “AB” if bioequivalent AB1, AB2… multisource drug products with two or more reference listed drugs B codes: drug products that FDA considers not TE to other PE products BC: Extended release (oral, injectable) products If bioequivalence data are available (they will be coded as AB) BD: Drugs with documented BE problems BE: Delayed release oral products BN: Products in aerosol-nebulizer drug delivery systems BP: Potential BE problems (e.g., parenteral suspensions) BR: Rectal dosage forms for systemic delivery BT: Topical products with bioequivalence issues (almost all dosage forms other than solution) BX: Insufficient data submitted BS: Products having drug standard deficiencies Therapeutic vs. generic substitution Generic sub: Cost-saving therapeutic alternatives: reduce cost, increase drug ude, prevent shortage, social and economical justification Hazardous Drugs: USP Chapter <800> Describe the scope of USP General Chapter <800> Describes standards for handling hazardous drugs to ensure safety of patient, worker, and environment Handling includes receipt, storage, compounding, dispensing, administration, and disposal Drugs that must following: any hazardous drug API, antineoplastic requiring manipulation Some drugs have dosage forms that don’t require all the containment requirements: Final dosage forms (tablets, capsules, injectable agents) do not require further manipulation Perform assessment of risk: Performed when full requirements of USP <800> are not met for a medication Working document that outlines the steps taken to reduce risk of exposure alternative containment strategies, different work practices protect employees Must contain the following: Type of HD, dosage form, risk of exposure, packaging, manipulation List the criteria for a hazardous drug, according to NIOSH Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria Three groups: 1- antineoplastic drugs 2- non-antineoplastic drugs that meet one or more NIOSH criteria for a hazardous drug 3- pose a risk to individuals actively trying to conceive, and/or those who are pregnant or breastfeeding Describe the primary and secondary engineering controls required for sterile compounding of hazardous drugs Primary: Example: C-PEC Ventilated device designed to minimize worker and environmental HD exposure Secondary: Example: C-SEC Room in which C-PEC is placed Supplemental: ex, CSTD Identify appropriate personal protective equipment (PPE) required for sterile compounding of hazardous drugs Gowns, head/hair covering, facial hair covering, shoe covers, two paids of chemotherapy gloves, eye face production, mask When to wear: Receipt, storage, transport, compounding, admin, deactivation/decontamination/cleaning/disinfecting, spill control, waste disposal Differentiate between the processes of deactivating, decontaminating, cleaning, and disinfecting Cleaning steps: deactivated, decontaminated, cleaned Deactivation: render compound inert or inactive Decontamination: remove HD residue Cleaning: remove organic and inorganic material Disinfection: destroy microorganisms Intro to Non-Sterile Compounding: Be familiar with reasons to compound or not compound Remove allergens (excipients), limited strength options, change dosage form, conceal taste, unavailable combo, change release of medication, animals/vet pharmacy, drug discontinued or on backorder Not to compound: Medication is commercially available, cost or monetary reasons is not a valid reason to compound, avoid compounding for food animal species, compounding does not apply to splitting tablets, reconstituting, repackaging. Recognize compounding regulations that apply to compounded nonsterile products State Board of Pharm: primary regulated by them Nonsterile compounding: must follow current revision of USP chapter 795 standards Compounding copies of an approved drug: may only compound preparations that are essentially copies of approved drugs if the compounded preparation is changed to produce for individual patient a clinically significant difference to meet a medical need as determined by prescriber. USP Standards: sets standards for compounding which states may choose to enforce, minimum requirements <795>: Everyone must undergo training, demonstrate competency and have refreshers every 12 motnhs Core competencies: hand hygiene, garbing, cleaning and sanitizing, handling and transporting components and CNSPs, measuring and mixing, proper use of equipment, documentation BUD: Significant changes Introduce concept of water activity Water- impacts microbial growth and degradation mechanisms FDA: drug quality and security act (DQSA_: Compounded drugs are not FDA approved, DQSA was created in 2013 to give FDA more authority to regulate and monitor compounding Helps regulate raw materials used in compounding Category 503A and 503B pharmacies Define common terms related to compounding Compare and contrast solutions and suspensions Identify the components of a non-sterile compounded formulation (active ingredient, inactive ingredient, wetting agent, base) and recognize common examples Active ingredient: manufactured tablets, capsules or liquids, bulk powder/liquid Solvent: Water, alcohol, glycerin, saline Suspending Vehicle: Ora-plus, methylcellulose, PCCA-plus, fixed oil Sweeter: aspartame, sucrose, sorbitol Flavoring Base vehicle: Ora-sweet, PCCA suspendit, Cheery syrup Preservatives: Benzalkonium chloride, benzyl alcohol, sodium benzoate Convert between common units (ex. Milligrams to grams, pounds to kilograms, milliliters to ounces) and solve calculations using these conversions 1 oz = 30 mL Compounding ointments and creams: Compare and contrast o/w versus w/o emulsions O/w: Oi in water Water is external (continuous phase) Not greasy Non-occlusive Can wash with water W/o: Water in oil Oil is external (continuous phase) Greasy Occlusive Not washable with water Compare and contrast ointments and creams Cream Topical dosage form for external use Liquid or semisolid Opaque, tends to vanish with rubbing, has more fluid-like consistency Useful for moist, weeping lesions Ointment Topical dosage form for external use Semisolid Soften or melt at body temperature, spreads easily, not gritty Useful for dry, scaly skin or lesions Identify the components of a non-sterile compounded ointment or cream formulation (active ingredient, inactive ingredient, wetting agent, base) and recognize common examples Active Ingredients: have therapeutic effect drug Base: Vehicle that holds the active ingredient together and the driver that gets the active ingredient where we want them to be in the body Aquaphilic, Aquaphor, Eucerin, white petrolatum Wetting agent: liquid chemicals used to wet a powder and facilitate uniform mixing into a liquid or semisolid, also known as levigating agent Propylene glycol, glycerin, mineral oil USP, castor oil, water Define common terms related to compounding ointments and creams Stiffening agent: Ingredient intended to make a preparation more viscous/ and or solid; example, white wax Humectants: decrease evaporation rate of water from the preparation; example, glycerine, polyethylene glycol Penetration enhancer: increase rate of penetration through the skin; example, water and many others Understand percentage preparations and be able to use this when performing pharmacy calculations Provide counseling points to patients using compounded topical formulations