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Practice Basics

Practice Basics. Chapter 16: Aseptic Technique, Sterile Compounding, and IV Admixture Programs . Learning Outcomes. Describe basics of intravenous drug therapy Describe key elements of working in laminar airflow workbenches

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Practice Basics

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  1. Practice Basics Chapter 16: Aseptic Technique, Sterile Compounding, and IV Admixture Programs

  2. Learning Outcomes • Describe basics of intravenous drug therapy • Describe key elements of working in laminar airflow workbenches • List types of contamination in a laminar flow hood & describe how to minimize their risks • Perform basic manipulations needed to prepare a sterile product by using aseptic technique • Describe the risks of handling cytotoxic & hazardous drugs

  3. Learning Outcomes • List steps in drug preparation & handling that are unique to cytotoxic & hazardous drugs • List typical ingredients of total parenteral nutrition solutions • Describe manual & automated means of preparing total parenteral nutrition solutions • Describe benefits of having a formal intravenous admixture program • Describe how USP 797 has impacted preparation of sterile products

  4. Key Terms • Aseptic technique • Biological safety cabinet • Coring • Free –flow protection • HEPA filter • Laminar airflow workbench (LAFW) • Large volume parenteral (LVP) • Total parenteral nutrition (TPN) • Small volume parenteral (SVP)

  5. Parenteral Drug Administration Parenteral – “not through digestive tract” • Intravenous (IV) • Intramuscular (IM) • Intrathecal (IT) • Epidural • Intraarticular • Intraarterial • Intraocular • Intraperitoneal • Subcutaneous (SQ, SC, SubQ)

  6. Risks of Intravenous Therapy • Infection • Air embolus • Bleeding • Allergic reaction • Incompatibilities • Extravasation • Particulate Matter • Pyrogens • Phlebitis

  7. Types of IV Administration • Infusions • Continuous • Intermittent

  8. IV Containers • Large Volume Parenterals (LVPs) • Small Volume Parenterals or “Piggyback” Systems • Add-Vantage® • Vial Spike Systems • Flexible Plastic Bags • Glass Containers

  9. Basic Continuous IV Therapy • Large volume parenteral (LVP) • hung on an IV pole 36 inches above patient’s bed • flow maintained by gravity • Sterile tubing attached to LVP • primary IV set • Catheter in patient’s vein

  10. LVP • Usually a simple solution of • dilute dextrose • sodium chloride • or combination of both • Additives • swab rubber stopper with alcohol & let dry • inject drug into fluid • remove bottle vacuum

  11. Non-coring Technique

  12. Administration Systems • Continuous Infusions • more effective & less toxic than when given intermittently • basic fluid & electrolyte therapy • blood products • drugs that require tight administration control • Intermittent Injections • periodic administration increases efficacy • reduces toxicity

  13. Pre-Mixed Admixtures • Manufactured LVPs with additives • stable in solution for longer periods of time • available in many of sizes (250 mL, 500 mL, 1000 mL) • Examples • lidocaine • potassium • nitroglycerin • dopamine • aminophylline

  14. RTU Advantages • Reduce handling by pharmacy • Reduce potential for contamination • Emergency situations-stocked in patient care area • Standard concentrations of IV medications • decrease potential medication errors in compounding & administration

  15. Pharmacy Prepared Admixtures • Volumes (100 mL, 250 mL, 500 mL, or 1000 mL) • Containers (glass, plastic, bag, bottle or syringe) • Syringe Systems • syringe pumps • volume control chambers • gravity feed • intravenous push systems

  16. Syringe Systems • Pharmacy fills syringes with drugs & labels • stability in syringes related to drug concentration • Syringe Pumps • adjusted to administer volume over given period of time • pumps are operated by battery or compressed spring • may administer single dose or pre-programmed intervals • doses must be sent from pharmacy in standard syringe sizes & concentrations

  17. Electronic Infusion Devices • Electronic infusion devices • increase precision & accuracy • in fluid restricted patients • when drug must be administered at precise rate • “Smart pumps” alert user to problems • infusion settings outside recommended range • updates may be sent to pumps • pump log data may be sent to information system

  18. Volume Control Chambers • Buretrol or Volutrol • Syringes used to administer drugs through volumetric chamber • drug injected through port on top of chamber • solution added from primary LVP • minimal amounts of fluid can be given per dose • beneficial in fluid-restricted or pediatric patients • important that medication is followed by IV flush

  19. Gravity Feed • Syringes can use gravity to administer drugs • vented set allows air to enter syringe • inexpensive & requires no other special equipment • Intravenous Push • injected directly into IV tubing • primary IV set is usually clamped off • Drug delivered directly to patient • Rapid onset of effects of drug

  20. Patient Controlled Analgesia • Very effective in managing pain • Patient administers dose as soon as pain felt • Reduces nursing time • Pump programmed • Basal rate • Bolus when patient pushes button • Example: max 1 mg of morphine every 15 minutes • If patient pushes button in 10 minutes, drug not released but attempt recorded so that pump tracks if pain not controlled

  21. Unique Infusion Devices • Implanted pump • drug reservoir for continuous low-dose chemotherapy administration • Elastomeric infusion device (EID) • acts as its own pump • pressure of container forces drug through tubing

  22. Administration Sets • Primary IV Set • attached to the LVP • can be one of several varieties • Drip chamber-estimate administration rate by counting drops as they fall through chamber • Drip chamber • macrodrip or minidrip • based on size of drop • tubing is labeled according to number of drops it produces from 1 milliliter of solution

  23. Drip Sets • Macro-drip sets deliver 10-20 drops per 1 mL • Minidrip sets deliver sixty drops per 1 mL • Rate controlled by roller clamp or electronic infusion device • Drugs injected through ports • either Y-sites or flashballs

  24. Venous Access Devices • Peripheral insertion most common • Peripheral catheters-limitations on what can be infused & at what rate • Central catheter • more complicated • riskier to insert & maintain • fewer restrictions • concentration of drug • rate of administration • time venous access can remain in place

  25. Peripheral Catheters • Plastic-flexible & most comfortable for patient • Steel needle with short end of tubing • scalp vein or butterfly • may be left in the patient’s vein if flushed • Central catheters • temporary or permanent • access vein with high blood flow

  26. Catheter Examples • Permanent catheters • Hickman® • Broviac® • Port-a-cath® • Peripheral catheter • “peripherally inserted central catheter” (PICC) • PICC inserted peripherally • flexible catheter threaded through venous system & its tip ends near heart • high volume of blood flow

  27. IV Miscellaneous Information • Heparin Lock • maintain catheter access to vein • resealable rubber diaphragm • provide port for intermittent use • concentration of heparin used in heparin locks is usually 10 units/mL or 100 units/mL • Needleless Systems • reduce risks of needle sticks • required in some states & some healthcare systems

  28. IV Misc. Information Continued • Final Filters • located in the tubing • used to remove particles in IV solution • used with drugs that have a risk of particulate matter or crystals in final solution • examples of drugs requiring filters • phenytoin • mannitol

  29. Aseptic Preparation • Admixture preparation program includes: 1. Development & maintenance of good aseptic technique in personnel who prepare & administer sterile products 2. Development & maintenance of sterile compounding area, complete with sterilized equipment & supplies 3. Development & maintenance of skills needed to properly use laminar airflow workbench (LAFW) or laminar airflow hood

  30. Aseptic Technique • Manipulating sterile products without compromising their sterility • proper use of LAFW • strict aseptic technique • Conscientious work habits

  31. Sterile Compounding Area • Compounded sterile products (CSPs) must be free of • living microorganisms • pyrogens • visible particles • Reduce number of particles in air • no cardboard in clean room • Clean work surfaces & floors daily • Clean walls, ceilings, & shelving monthly

  32. Sterile Compounding Area • Segregate compounding area • minimize traffic in sterile compounding area • remove trash d frequently & regularly • Filter incoming air • Ultraviolet irradiation • Air-lock entry portals • Sticky mats

  33. Sterile Compounding Area • Use anteroom for non-aseptic activities • order processing • gowning • handling of stock • ISO Class 5 environment • no more than 100 particles per cubic foot that are 0.5 micron or larger in size • LAFWs are used to achieve an ISO Class 5 environment

  34. Laminar Airflow Workbenches • Principle of LAFWs • twice-filtered laminar layers of aseptic air • continuously sweep work area inside hood • prevents entry of contaminated room air • 2 common types of LAFWs • horizontal flow • vertical flow

  35. IV Hoods Vertical Hoods used for preparing hazardous medications Designed to protect preparer from exposure to hazardous medications Horizontal Hoods most common for sterile preparation of IV solutions

  36. Horizontal LAFW • Air moves from back to front • Electrical blower draws room air through a prefilter • Removes gross contaminants • Should be cleaned or replaced on regular basis • Prefiltered air moves through final filter • Entire back portion of hood’s work area is HEPA • high efficiency particulate air • Removes 99.97% of particles that are 0.3 micron or larger

  37. Vertical LAFW • Air emerges from the top and passes downward • Exposure to airborne drug particulates minimized • Used for preparation of antineoplastics • Referred to as biological safety cabinets (BSCs) • Space between the HEPA filter and the sterile object • critical area. • Must prevent downstream contamination • Zone of turbulence

  38. LAFW Principles • Position away from excess traffic, doors, air vents, etc. • Must run for 15 -3o minutes if turned off & back on • All interior working surfaces should be cleaned • 70% isopropyl alcohol/other disinfecting agent • clean, lint-free cloth

  39. Cleaning LAFWs • Clean sides of hoods using up & down direction • start at HEPA • work toward outer edge of hood • Order of cleaning • walls 1st • floor of hood 2nd

  40. Cleaning LAFWs • Frequency • beginning of each shift • before each batch • not longer than 30 minutes following previous surface disinfection when ongoing compounding activities are occurring • after spills • when surface contamination is known or suspected

  41. Cleaning LAFWs • If materials not soluble in alcohol, initially use water • follow with alcohol • Do not use spray bottles of alcohol in hood • Let alcohol air dry • Clean Plexiglas sides -warm, soapy water • Alcohol will dry out Plexiglas • clouds & cracks

  42. Additional LAFW Instructions • Nothing should come in contact with HEPA filter • Nothing in hood that is not essential IV preparation • no paper, pens, labels, or trays • No jewelry on hands or wrists • Talk & cough away from LAFW • No smoking, eating, drinking in aseptic area • Manipulations at least six inches within hood

  43. Additional LAFW Instructions • Must test LAFWs at least every 6 months • Also test if hood moved, or if filter damage suspected • Specific tests • airflow velocity • HEPA filter integrity • Strict aseptic technique must be used

  44. Aseptic Environment • Personal Attire -Cover • Shoes, head & facial hair, use face masks/eye shields • cover scrub suits when leaving pharmacy • Handwashing • touch is most common source of contamination • scrub hands, nails, wrists, forearms to elbows for at least 30 seconds with a brush, warm water, & appropriate bactericidal soap • Gloving • only sterile until they touch something unsterile

  45. Equipment & Supplies • Syringes

  46. Syringes • Volume of solution- 1/2 to 2/3 of syringe capacity • Measuring-line up final edge to calibration mark on barrel • Open syringe package in hood to maintain sterility • Peel wrapper & discard out of hood • Leave syringe tip protector in place until time to attach needle • To attach needle to Luer-lock-type syringe ¼ turn is usually sufficient to secure needle to syringe

  47. Needles • Note components • Often color-coded=gauge • Vented needles • Filter needles • Dead space

  48. Vials • Rubber stopper • Powders or liquids • 70% isopropyl alcohol • Avoid coring • Normalize pressure • Reconstitution • SDV or MDV • Preservative considerations

  49. Ampules • Move fluid to body of ampule • Swab neck with alcohol pad • Break at neck • Tilt ampule, needle bevel down • Use filter needle

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