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Aseptic Technique, Sterile Compounding: Intravenous and Admixture

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Title: Aseptic Technique, Sterile Compounding: Intravenous and Admixture


1
Aseptic Technique, Sterile CompoundingIntravenou
s and Admixture
  • Lecture 1
  • IV PREPARATION COURSE

2
Aseptic Technique
  • Aseptic technique is the term used for all
    procedures and techniques performed to keep a
    sterile product from becoming contaminated.

3
Parenteral Drug Administration
  • Basic Intravenous Therapy
  • - Intravenous (IV) route of administrations is
    the most
  • common route that parenteral dose are
    administered
  • today.
  • - Other parenteral dosage forms are
  • 1. intramuscular (IM)
  • 2. subcutaneous (SubQ)
  • 3. intradermal (ID)
  • 4. epidural
  • - IV fluid is in a large-volume parenteral
    (LVP), usually
  • more than 100 mL

4
Basic IV Therapy cont
  • - Hang on an IV pole approximately 36 inches
    higher than
  • the patients bed.
  • - The LVP is usually a simple solution of dilute
    dextrose,
  • sodium chloride or both.
  • - Solution is infused continually to keep blood
    from clotting
  • in the catheter and plugging the line.

5
Basic IV Therapy cont
  • - Primary IV set attaches to the LVP. Most IV
    sets that
  • flow by the force of gravity have several
    common features
  • 1. Drip chambers are typically
    classified as macrodrip
  • or minidrip based on the size of
    the drop that is
  • formed in the drip chamber.
  • a. Macrodrip deliver 10 to
    20 drops/mL
  • b. Minidrop or Microdrip
    deliver 60 drops/mL
  • 2. Electronic infusion devices are
    usually used in fluid
  • restricted patients or when the
    LVP contains a drug
  • that must be administered at a
    precise rate that
  • cannot be monitored by using the
    gravity method.

6
Continued
  • - Secondary IV sets drugs that are routinely
    delivered
  • through the same basic IV setup are
    usually attached to
  • a secondary IV set connected to the
    primary set.
  • - Catheters typically inserted into a
    peripheral vein (arm,
  • leg, or hand) or a central vein (in the
    chest near the
  • heart).
  • 1. Where the catheter is inserted
    depends on the
  • contents of the IV
  • 2. Peripheral insertion is more
    common than central
  • insertion
  • 3. The central catheter is more
    complicated and riskier
  • to insert and maintain, but has
    fewer restrictions with
  • respect to type and rate of
    administration

7
Continued
  • 4. Types of peripheral catheters
  • a. Plastic most common
  • b. Steel commonly referred to as a
    scalp vein or
  • butterfly. Used in patients that
    require IV therapy
  • who are still capable of eating
    and drinking, do not
  • require supplemental fluids, and
    might be ambulatory.
  • 5. Central catheters can be temporary used for
    days or weeks
  • (such as during a hospital stay) or
    permanent, when used
  • for months or years (such as home care or
    cancer patients)

8
Continued
  • 6. The central catheter gives direct access into
    a vein that
  • that has a high flow of blood.
  • 7. Peripheral inserted central catheter (PICC)
    offers some of
  • the benefits of both central and peripheral
    catheters.
  • Inserted peripherally it is a long flexible
    catheter that
  • travels through the vein and its tip ends
    near the heart
  • where there is a high volume of blood flow.

9
Risks of Intravenous Therapy
  • Infection results if a product contaminated
    with bacteria is infused into a patient.
  • - human touch contamination continues to be the
    most
  • common source of IV related contamination.
  • Air embolus incidence is low, because many
    solutions are administered using infusion pumps
    equipped with an alarm that sound when air is in
    the IV line. These are called air-in-line alarms.
  • - in adults it takes 150 or 200 mL of air (much
    less in
  • infants or pediatric patient) given
    quickly to result in
  • harm.

10
Risks continued
  • Bleeding when the IV catheter is removed,
    bleeding may occur around the catheter site.
  • Allergic reaction when a patient has an
    allergic reaction to a substance given
    parenterally the reaction is usually more severe
    than if the same substance was given by another
    route (e.g. mouth, topically, or rectally)
  • - one reason for this is that substances given
    parenterally
  • cannot be retrieved like substances given
    by other routes.
  • Incompatibilities if an incompatibility exists,
    the drug might precipitate, be inactivated, or
    adhere to the container. Incompatible solutions
    should not be administered to patients.

11
Risks continued
  • Extravasation occurs when the catheter
    punctures and exits the vein under the skin,
    causing drugs to infuse or infiltrate into the
    tissue.
  • Particulate matter refers to particles present
    in parenteral products. When injected into the
    bloodstream can cause adverse effects to the
    patient. Examples
  • - microscopic glass fragments
  • - hair
  • - lint or cotton fibers
  • - cardboard fragments
  • - undissolved drug particles
  • - fragments of rubber stoppers

12
Risks continued
  • Pyrogens the by-products or remnants of
    bacteria, can cause reactions (e.g. fever and
    chills) if injected in large enough amounts.
  • Phlebitis Irritation of the vein. Caused by
  • - the drug being administered (due to it
    chemical properties
  • or its concentration)
  • - the location of the IV site
  • - a fast rate of administration
  • - the presence of particulate matter
  • - the patient usually feels pain or discomfort
    along the path
  • of the vein (often severe) and red
    streaking may also
  • occur

13
Aseptic Preparation of Parenteral Products
  • Aseptic Technique
  • - Programs designed to ensure the aseptic
    preparation of
  • sterile products.
  • - The main elements these programs focus on are
  • 1. the development and maintenance of good
    aseptic
  • technique in the personnel who
    prepare and
  • administer sterile products.
  • 2. Development and maintenance of a
    sterile
  • compounding are complete with
    sterilized equipment
  • and supplies.
  • 3. Development and maintenance of the
    skills needed to
  • properly use a laminar flood hood
    (LAH).

14
Aseptic Technique continued
  • Aseptic technique is a means of manipulating
    sterile products without contaminating them.
  • Proper use of a LAH and strict aseptic technique
    are the most important factors in preventing the
    contamination of sterile products.

15
Sterile Compounding Area
  • Sterile parenteral solutions must be free of
    living microorganisms and relatively free of
    particles and pyrogens.
  • A sterile compounding area should be cleaned
    daily and segregated from normal pharmacy
    operations, patient specimens, nonessential
    equipment, and other materials that produce
    particles. Examples
  • - cardboard into the clean environment should be
    avoided.
  • - traffic flow should be minimized.
  • - floors should be disinfected periodically.
  • - trash should be removed frequently and
    regularly.

16
Compounding Area continued
  • Sterile products should be prepared in a Class
    100 environment, which contains no more than 100
    particles per cubic foot that are 0.5 micron or
    larger in size.
  • LAHs are frequently used to achieve a Class 100
    environment.

17
Laminar Airflow Hoods (LAH)
  • Underlying principle of LAHs is that
    twice-filtered layers of aseptic air continuously
    sweep the work area inside the hood to prevent
    the entry of contaminated room air.
  • Two common types
  • - Horizontal LAH sweeps filtered air from the
    back of the
  • hood to the front.
  • 1. use an electrical blower to draw
    contaminated room
  • air through a prefilter.
  • 2. The prefilter, which is similar to a
    furnace filter, only
  • removes gross contaminants and needs
    to be cleaned
  • or replaced on a regular basis.
  • 3. The high efficiency particulate air
    or (HEPA) filter
  • removes 99.9 of particles that are
    0.3 micron or
  • larger.

18
Laminar Airflow Hoods continued
  • Vertical LAH HEPA filtered air emerges from the
    top and passes downward through the work area.
  • - used for antineoplastic (anticancer) drugs.
  • - the risk of exposure to airborne drug
    particulates is
  • minimized.
  • - the type of vertical LAH used for the
    preparation of
  • antioneoplastics contains airflow within
    the hood and are
  • referred to as biological safety cabinets
    (BSCs).
  • The critical principle of using LAHs is that
    nothing interrupts the flow of air between the
    HEPA filter and the sterile object. The space
    between the HEPA filter and the sterile object is
    known as the critical area.

19
Hoods continued
  • To maintain sterility, nothing should pass behind
    a sterile object in a horizontal flow hood or
    above a sterile object in a vertical flow hood.
  • Materials placed within the laminar flow hood
    disturb the patterned flow of air blowing from
    the HEPA filter. This zone of turbulence
    created behind an object could potentially extend
    outside the hood pulling or allowing contaminated
    room air into the aseptic working area.
  • It is advisable to work with objects at least six
    inches from the sides and front edge of the hood
    without blocking air vents, so that unobstructed
    airflow is maintained between the HEPA filter and
    sterile objects.

20
Hoods continued
  • The following are general principles for
    operating LAHs properly
  • - A LAH should be positioned away from excess
    traffic,
  • doors, air vents, or anything that could
    produce air currents.
  • - If turned off, it should be allowed to run for
    15-30 minutes
  • before use.
  • - Before use, all interior working surfaces of
    the laminar
  • flow hood should be cleaned with 70
    isopropyl alcohol or
  • other appropriated disinfecting agent and
    a clean, lint-free
  • cloth. Cleaning should be performed from
    the HEPA filter
  • toward the front of the LAH (in a
    horizontal LAH) so that
  • contaminants are moved out of the hood.

21
Hood Criteria continued
  • Nothing should be permitted to come in contact
    with the HEPA filter. This includes cleaning
    solution, aspirate from syringes, or glass from
    ampules. Ampules should not be opened directly
    toward the filter.
  • Do not put paper, pens, labels, or trays into the
    hood.
  • Jewelry should not be worn on the hands or wrists
    when working in the LAH since it may introduce
    bacteria or particles into the clean work area.
  • Actions such as talking and coughing should be
    directed away from the LAH working area, and any
    unnecessary motion within the hood should be
    avoided to minimize the turbulence of air flow.

22
Hood Criteria continued
  • Smoking, eating or drinking are prohibited in the
    aseptic environment.
  • All aseptic manipulations should be performed at
    least six inches within the hood to prevent the
    possibility of potential contamination caused by
    the closeness of the workers body and backwash
    contamination resulting from turbulent air
    patterns developing where LAH air meets room air.
  • LAHs should be tested by qualified personnel
    every six months, whenever the hood is moved, or
    if filter damage is suspected.

23
Personal Attire
  • The first component of good aseptic technique is
    proper personal attire.
  • Clean garments, which are relatively particulate
    free, should be worn when preparing sterile
    products.
  • Many facilities provide clean scrub suits or
    gowns for this purpose.
  • Hair covers and shoe covers help reduce
    particulate or bacterial contamination, and some
    experts claim that the use of surgical masks and
    gloves is warranted as well.

24
USP 797 New Standards
  • The primary structure of the new USP standards is
    based on 3 risk levels classified according to
    the potential for
  • - Microbial contamination
  • (microorganisms and endotoxins)
  • - Physical contamination
  • (particulate contaminants from cotton
    garments,
  • cardboard cartons, pencils, paper
    towels, chewing gum
  • and electronic equipment)
  • - Chemical contamination
  • (solid or liquid matter from
    precipitates)

25
Standards continued
  • There are specific standards for each risk level.
  • Standards regarding personnel training,
    environmental quality and control, verification
    of compounding accuracy, packing and transport,
    adverse event reporting, storage, and beyond-use
    dating.

26
Risk Levels Low Risk
  • Definition
  • - All aseptic manipulations
  • within class 100
  • environment using only
  • sterile ingredients and
  • devices
  • - Only single transfers
  • used
  • - Measuring/mixing no more
  • than 3 products
  • Examples
  • - Single patient doses
  • - Single patient syringe w/o
  • additives
  • - Batch syringes with
  • preservatives
  • - Sterile solution withdrawn
  • from an amp and filtered to
  • remove glass particles
  • - Manually prepared TPN
  • with three ingredients

27
Risk Levels Medium Risk
  • Definition
  • - No Broad Spectrum
  • antibacterial present
  • despite administration over
  • several days
  • - Complex aseptic
  • manipulations
  • - Multiple doses in one
  • container for multiple
  • patients or one patient on
  • multiple occasions
  • Examples
  • - Batch reconstituted
  • antibiotics without
  • preservatives
  • - Batch syringes w/o
  • preservative
  • - Filling reservoirs with
  • multiple sterile products and
  • evacuating air for
  • administration over several
  • days at room temperature
  • - TPN prepared by a
  • compounder

28
Risk Levels High Risk
  • Definition
  • - Sterile products
  • compounded from
  • nonsterile ingredients or
  • use of a nonsterile device
  • prior to terminal
  • sterilization
  • - Sterile ingredients,
  • components, or devices
  • exposed to air quality lt
  • class 100 if opened or
  • partially used and not
  • adequately preserved
  • Examples
  • - Mixing or measuring in
  • nonsterile devices
  • - Assuming 95 purity of
  • ingredients
  • - Injections made from
  • nonsterile powder that will
  • be terminally sterilized
  • - Compounded bladder
  • irrigations
  • - TPN for terminal sterilization
  • by final filtration

29
Environmental Quality Control
  • Work bench area where compounding is completed
  • Buffer area clean room area immediately
    surrounding the work bench. Should not contain
    any drains or sinks.
  • Ante area Space beyond the buffer area where
    hand sanitizing and gowning occurs.
  • - includes hands free faucets and air dryers or
    low-shedding
  • towels.
  • - Supplies are unpacked and disinfected for
    storage in the
  • ante room.

30
Environmental Quality Control
  • General Requirements
  • - Must limit tasks performed in the buffer area
    to those
  • directly related to compounding.
  • - 2 stainless steel carts with cleanable
    castors
  • 1. one for buffer area
  • 2. collecting medications solutions
    and supplies that
  • are cleaned and sanitized before
    being transferred
  • to the buffer cart for
    compounding.

31
Environmental Quality and Control
  • Compounding personnel must be properly garbed in
    clean room
  • FYI A motionless person sheds 100,000 particles
    every 60
  • secondsSkin flakes, hair, salt, oils,
    moisture droplets,
  • even deodorant.
  • For all risk levels
  • Hair covers, shoe covers, knee-length coats or
    coveralls with
  • Snug writs and front closures face masks, and
    gloves

32
Training and Performance
  • Documentation for Tech training
  • Prior to commencing any compounding, perform a
    thorough didactic instruction in the theory and
    practice of sterile preparations, with evaluation
    of technique
  • - annually for low and medium risk levels
  • - semiannually for high risk levels
  • Compounder evaluations should include a formal
    written exam and practical evaluation of aseptic
    technique using growth media

33
Handwashing
  • Touching sterile products while compounding is
    the most common source of contamination of
    pharmacy prepared sterile products.
  • Scrub your hands, nails, wrists, and forearms
    thoroughly for at least 30 seconds with a brush,
    warm water, and appropriate bactericidal soap
    before performing aseptic manipulations. Wash
    your hands frequently and every time you re-enter
    the sterile compounding area.
  • Workers who have open sores on their hands or
    have an upper respiratory tract infection should
    inform their supervisor and/or consult the
    institutions quality assurance procedures. Wear
    sterile gloves and mask is needed.

34
Equipment and Supplies
  • Another important factor in aseptic preparation
    of sterile products is the correct use of
    appropriate sterile equipment and supplies,
    including syringes and needles.
  • Syringes
  • - made of either glass or plastic
  • - most drugs are more stable in glass, so glass
    syringes
  • are most often used when medication is to
    be stored in
  • the syringe for an extended period of
    time.
  • - Composed of a barrel and plunger. To maintain
    sterility
  • of the product, do not touch the syringe
    tip or plunger.
  • Many syringes have a locking mechanism at
    the tip
  • Leur-lock, which secures the needle within
    a threaded
  • ring.

35
Syringes continued
  • Available in numerous sizes ranging from 0.5 to
    60 mL. Usually the larger the syringe capacity,
    the larger the interval between calibration
    lines.
  • Ideally, the volume of solution should only take
    up ½ to 2/3 of the syringe capacity. This avoids
    inadvertent touch contamination caused when the
    syringe plunger is pulled all the way back.
  • When measuring with a syringe, lineup the final
    edge (closest to the tip of the syringe) of the
    plunger piston, which comes in contact with the
    syringe barrel, to the calibration mark on the
    barrel which corresponds to the volume desired.

36
Syringes continued
  • The syringe package should be opened within the
    laminar flow hood in order to maintain sterility.
  • The wrapper should be peeled apart and not ripped
    or torn.
  • To minimize particulate contamination, do not lay
    discarded packaging on the LAH work surface.
  • The syringe tip protector should be left in place
    until it is time to attach the needle.

37
Needles
  • Sizes are described by two numbers
  • - Gauge corresponds to the diameter of its
    bore, which is
  • the diameter of the inside of the shaft.
    The larger the
  • gauge the smaller the needle bore.
  • Ex the smallest needles have a gauge of
    27, the
  • largest needles have a gauge of
    13.
  • - Length the needle shaft is measured in inches
    and
  • usually ranges from 3/8 to 3 ½ inches.

38
Needles continued
  • Components of a simple needle
  • - Hub attached the needle to the syringe and is
    often
  • color-coded to correspond to a specific
    gauge.
  • - Shaft the tip of the needle shaft is slanted
    to form a
  • point. The slant is called the bevel, the
    point is called the
  • bevel tip. The opposite end of the slant
    is termed the
  • bevel heel.
  • No part of the needle itself should be touched.
    Needles should be manipulated by their over-wrap
    and protective covers only. The protective cover
    should be left in place until the needle and/or
    syringe are ready to be used.

39
Needles continued
  • A needle shaft is usually metal and is lubricated
    with a sterile silicone coating.
  • - For this reason, needles should never be
    swabbed with
  • alcohol.
  • Some needles have built in filters and are meant
    to be used with products requiring frequent such
    as drugs removed from a glass ampule.

40
Drug Additive Containers
  • Ampules
  • - Composed entirely of glass and once broken
    (opened)
  • become open-system containers
  • - Since air or fluid may now pass freely in and
    out of the
  • container, it is not necessary to replace
    the volume or
  • fluid to be withdrawn with air.
  • - Before an ampule is opened, any solution
    visible in the
  • top portion (head) should be moved to the
    bottom (body)
  • by swirling the ampule in an upright
    position, tapping the
  • ampule with your finger or inverting the
    ampule and then
  • quickly swinging it into an upright
    position.

41
Ampule continued
  • To break an ampule properly, the head must be
    broken from the body of the ampule. To make the
    break properly, the ampule neck is cleansed with
    an alcohol swab and the swab should be left in
    place.
  • To withdraw medication from an ampule, the ampule
    should be tilted and the bevel of the needle
    placed in the corner space (or shoulder) near the
    opening.
  • To withdraw the solution, either use a flter
    needle and change to a regular needle BEFORE
    expelling the contents. Either way, the filter
    needle must not be used for both withdrawing from
    the ampule and expelling from the syringe,
    because doing so would nullify the filtering
    effort.

42
Ampules continued
  • Usually the medication is withdrawn from the
    ampule with a regular needle and then the needle
    is changed to a filter needle before pushing drug
    out of the syringe.

43
Vials
  • Is a glass or plastic container with a rubber
    stopper secured to its top, usually by an
    aluminum cover.
  • They are used to hold powders and liquids.
  • The rubber stopper is usually protected by a
    flip-top cap or aluminum cover.
  • Most protective covers do not guarantee sterility
    of the rubber stopper therefore, before the
    stopper is penetrated, it must be swabbed with
    70 isopropyl alcohol and allowed to dry.

44
Vials continued
  • Swabbing helps achieve sterility in two ways
  • - the alcohol acts as a disinfecting agent
  • - the physical act of swabbing in one direction
    removes
  • particles.
  • When piercing vials with needles, avoid coring
    fragments out of the rubber stopper with the
    needle.
  • - a core is carved out of the rubber stopper
    when the
  • bevel tip and the bevel heel do not
    penetrate the stopper
  • at the same point.
  • Vials are closed-system containers since air or
    fluid cannot pass freely in or out of them.

45
Vials continued
  • In most cases, air pressure inside the vial is
    similar to that of room air.
  • In order to prevent the formation of a vacuum
    inside the vial (less pressure inside the vial
    than room air) the used should normalize pressure
    by first injecting into the vial a volume of air
    equal to the volume of fluid that is going to be
    withdrawn.
  • If the drug is in powdered form, it has to be
    reconstituted. Inject the desired volume of
    sterile diluting solution (the diluent), such as
    sterile water for injection, into the vial
    containing the powdered drug.

46
Vials continued
  • An equal volume of air must be removed in order
    to prevent a positive pressure from developing
    inside the vial.
  • Vials with drugs in solution are classified as
    multiple-dose (also called multiple use) or
    single-dose.
  • Multiple-dose vials contain a small amount of a
    preservative agent, added to retard the growth of
    bacteria or other organisms that inadvertently
    contaminate a product.
  • Single-dose vials have no preservative and are
    intended to be used one time only. Once a vial is
    entered with a needle, it should be discarded.

47
Pre-filled Syringes
  • Drugs commonly given IM or IV are packaged this
    way to make them convenient for the health care
    provider.
  • It is also done if the drug is commonly used in
    emergency situations because a pre-filled syringe
    saves time.

48
Preparation of Intravenous Admixtures
  • Before compounding assemble all materials and
    visually inspect vials, ampules, and IV solution
    containers for signs of cloudiness, particulate
    matter, cracks and punctures, expiration dates,
    and anything else that may indicate that the
    product is defective.

49
Preparation continued
  • Next, disinfect all injection surfaces and allow
    them to dry.
  • - Flexible plastic bag made of polyvinyl
    chloride (PVC)
  • are frequently used.
  • - Easier to store, less breakable than glass
    bottles, and
  • eliminates the need to vent the
    container when
  • removing fluid.
  • - The protective overwrap should not be
    removed from
  • a PVC bag until it is ready to be
    used.
  • - To minimize air turbulence in the critical
    area, position
  • the injection port of a PVC bag,
    which is covered by an
  • outside latex tip diaphragm, toward
    the HEPA filter
  • when preparing an IV admixture.

50
Disposal of Supplies
  • Syringes and uncapped needles should be discarded
    according to institutional policy.
  • Never recap a needle. Lay the syringe
    horizontally and slide the cap onto the needle.
    Or place the syringe vertically and drop the cap
    onto the needle.
  • In some institutions supplies are discarded in
    puncture-resistant, sealable containers often
    called sharps containers.

51
Labeling
  • Properly label the IV with the following
    information
  • - Patient name, ID number and room number (if
    inpatient)
  • - Bottle or bag sequence number, when
    appropriate
  • - Name and amount of drugs(s) added
  • - Name and volume of admixture solution-
    Auxiliary labeling
  • - Approximate final total volume of the
    admixture, when
  • applicable
  • - Prescribed flow rate (in mLs per hour)
  • - Date and time of scheduled administration
  • - Date and time of preparation
  • - Expiration date
  • - Initials of person who prepared and person who
    checked
  • the IV admixture
  • - Auxiliary labeling supplemental instructions
    and precautions
  • - Typically drugs are considered stable as long
    as they are
  • within 10 of their labeled potency.

52
Administration Systems for Parenteral Products
  • Continuous Infusions
  • - More effective and less toxic than when given
  • intermittently.
  • - Includes
  • 1. Basic fluid and electrolyte therapy
  • 2. Blood products
  • 3. Specific drugs that require tight
    administration
  • control to minimize adverse effects

53
Parenteral Systems continued
  • Intermittent Injections
  • - Used to administer medications that work
    better when
  • infused at defined time intervals rather
    than when infused
  • continuously.
  • - Examples of drugs commonly given
    intermittently are
  • 1. antibiotics
  • 2. drugs used to treat or prevent
    gastrointestinal
  • ulcers

54
Intermittent Injections continued
  • - Types of systems for intermittent injections
  • 1. Large Volume Parenterals (PVC)
  • a. Usually defined as those IV
    solutions containing
  • more than 100 mL
  • b. Usually infused as solutions of
    dilute dextrose
  • and/or sodium chloride as
    continuous infusions
  • with or without additives, but
    they can be used
  • for intermittent infusions as
    well.
  • - Commercially Available
  • 1. Preparations with additives are used in
    standard
  • concentrations, are stable in solution
    for long periods of
  • time.
  • 2. Available in a variety of sizes and
    containers
  • 3. Ready-to-use products are advantageous
    because they reduce
  • handling by the pharmacy, - the
    potential for contamination.

55
Intermittent Injections continued
  • - Pharmacy Prepared
  • 1. Made in the pharmacy to meet the
    specific needs of
  • patients
  • 2. Prepared in different volumes and
    different containers
  • Syringe Systems
  • - Most common drug delivery systems that use
    syringes are
  • 1. syringe pumps
  • 2. volume control chambers
  • 3. gravity feed
  • 4. intravenous push systems
  • - Require that the pharmacy fill syringes with
    drugs and label them.
  • - Stability may differ from the stability
    of the same drug in other
  • dosage forms because of concentration
    differences.

56
Intermittent Injections continued
  • Syringe Pumps
  • 1. Used to administer drugs by means
    of a specially
  • designed syringe pump and tubing
    set.
  • 2. Pumps are either operated by a
    battery or a
  • compressing spring.
  • 3. Pumps are also available to
    administer a single dose
  • per setup or a 12 or 24 hour
    supply at preprogrammed
  • intervals.
  • Volume Control Chambers (Buretrol or Volutrol)
  • 1. The drug is injected through a port
    on top of the
  • chamber, and solution is added
    from the primary LVP.
  • 2. With this system, minimal amounts
    of fluid can be given per
  • dose, a method that may be
    beneficial in fluid-restricted or
  • pediatric patients.

57
Intermittent Injections continued
  • Gravity Feed
  • 1. Tubing set has an air vent through
    which air enters
  • the syringe as fluid is pulled out
    by gravity.
  • 2. The system is relatively inexpensive and
    requires no
  • other special equipment.
  • Intravenous Push
  • 1. Drugs given by IV push are injected
    directly into the
  • IV tubing and pushed into the
    patient quickly.
  • 2. Injected into an injection port, a Y-site
    on the IV tubing,
  • or an injection flashball.
  • 3. Disadvantage difficult to control
    the rate of drug
  • delivery with a syringe and many
    drugs cause the
  • patient to experience adverse
    effects when given too
  • quickly.

58
Intermittent Injections continued
  • Small Volume Parenterals (Piggyback Systems)
  • 1. Common method for drug additives to a
    small
  • volume parenteral or piggyback (lt
    100 mL)
  • 2. The piggyback is placed higher than the
    primary IV
  • (usually an LVP) so that gravity
    causes the drug
  • solution to run into the patients
    vein before the
  • primary fluid.
  • 3. The back-check valve at the proximal
    Y-site closes
  • off while the piggyback is being
    administered, thus
  • preventing the piggyback solution
    from entering the
  • primary IV.

59
Intermittent Injections continued
  • Add-Vantage specially designed bag and a vial
  • Vial Spike System similar in concept to the
    Add-Vantage system not activated until just
    before administration.
  • Premixed Solutions often frozen and thawed by
    the pharmacy hours or days before administration.
  • Bags/bottles containing powder for reconstitution
    requires to be added to a bottle of 20 to 100
    mL of solution piggyback system
  • Controlled-release infusion system (CRIS)
    delivers medication directly form the vial to the
    primary IV solution.

60
Patient Controlled Analgesia (PCA)
  • A method of drug administration usually used with
    injectable pain medications, which is very
    effective in managing pain.
  • Two advantages of PCAs
  • - they eliminate the need for painful IM
    injections
  • - reduce patients anxiety about controlling
    their pain
  • Goals of PCA to relieve pain as soon as the
    patient recognizes a need for it.
  • - may also reduce nursing time associated with
    pain
  • medication administration.

61
PCA continued
  • Used with either a stationary or a portable pump.
  • The pump releases a programmed amount of the pain
    medication into the IV tubing when the patient
    pushes a button.
  • The pump is programmed to release an amount of
    pain medication that is specific for the
    patients weight and condition.
  • The pump is also programmed to limit how often
    the patient may push the button and receive pain
    medication.

62
PCA continued
  • The pump may be programmed to allow a patient to
    receive a maximum of 1 mg of drug every 15
    minutes. When the patient pushed the button, the
    pump injects 1 mg. If the patient pushes the
    button again in 10 minutes, the pump does not
    release the drug. If the patient pushes the
    button at least 5 minutes later (15 minutes since
    the last injection), the pump again administers 1
    mg. This is often referred to as a 15-minute
    lock-out period.
  • Differs from most other products in two ways
  • - if the patient does not have other means
    of pain control,
  • there might be an urgency to initiate
    therapy.
  • - these doses usually contain enough
    medication to last at
  • least 8 hours and often up to 24 hours or
    more.

63
Total Parenteral Nutrition Solutions
  • Definition
  • - Total parenteral nutrition (also known as
    hyperalimentation,
  • hyperal or TPN) is the IV administration
    of nutrients needed
  • to sustain life carbohydrates, protein,
    fats, water,
  • electrolytes, vitamins, and trace
    elements.
  • - Usually initiated in patients who cannot meet
    their
  • nutritional needs from other sources for
    an extended period
  • of time.
  • - TPN is used for patients who cannot eat (e.g.
    head neck surgery,
  • comatose, or before or after surgery),
    who will not eat (e.g.
  • patients with esophageal obstruction or
    inflammatory bowel
  • disease or who cannot eat enough (e.g.
    patients with cancer,
  • burns or trauma).

64
Components of Parenteral Nutrition Solutions
  • Contain base components and additives
  • - Base components are usually mixed first and
    make up
  • much of the volume of the TPN. Composed of
    dextrose
  • (carbohydrates) and amino acids (protein)
    and may
  • include fat and water.
  • - Additives are usually mixed with the base
    components
  • and include life-sustaining nutrients,
    electrolytes, vitamins,
  • trace elements as well as heparin, insulin
    and H2
  • antagonists.

65
Additives continued
  • Carbohydrates usually administered in the form
    of dextrose because of its low cost and easy
    availability. Usually a 50 70 solution is used
    in TPN preparation, and the final dextrose
    concentration in the TPN is usually around 25
    for solutions administered via central vein.
  • Protein required for tissue synthesis and
    repair, transport of body nutrients and waste,
    and maintenance of immune function. These
    solutions are available in concentrated form,
    such as 8.5 10 and diluted in the compounding
    process.

66
TPN continued
  • Fats (lipids) are usually administered as fat
    emulsions. Administered as a source of calories.
    Available as 10 to 20 emulsions dispensed in a
    separate container given through a peripheral IV
    line. Fats can be added to the TPN solution
    (3-in-1 solution or total nutrient admixture).
    Considered a third base component along with
    dextrose and amino acids.
  • Water in all preparations and is usually
    derived from the components used in the
    preparation. The purpose of adding water is to
    offset normal bodily losses and prevent
    dehydration.

67
TPN continued
  • Electrolytes needed to meet daily metabolic
    needs and correct deficiencies. Usually include
    sodium, potassium, chloride, acetate, phosphate,
    magnesium, and calcium.
  • Vitamins usually administered in a standard
    formulation o fat and water-soluble vitamins and
    are often abbreviated as MVI. When vitamin K
    (phytonadione) is needed it is usually given
    separately as an IM injection.
  • Trace elements required for proper enzymatic
    reations and for use of energy sources in the
    body. Typical elements administered are copper,
    zinc. Chromium, manganese, selenium and iron.

68
TPN continued
  • The proper order of mixing is
  • - add the fats first (adding concentrated
    dextrose may oil
  • out or crack the emulsion)
  • - the amino acid second
  • - the dextrose last
  • - remember the acronym FAD fats, amino acids,
    dextrose
  • - this mixing order dilutes and buffers the fat
    emulsion with
  • amino acids before the highly concentrated
    and acidic
  • dextrose is added.

69
Automated Compounding
  • Three primary pieces of equipment are used,
    sometimes together and sometimes individually.
  • - An automated compounder prepares the base
    components
  • dextrose, amino acids, and possibly fat
    emulsion H20
  • - A second automated compounder adds most or
    all of the
  • additives or other components
  • - A computer with software maintains the orders
    of the
  • ingredients and controls the two
    compounders.

70
Compounding continued
  • The base compounder accounts for the specific
    gravity of the solutions being used and actually
    weighs the amount pumped into the final
    container.
  • The additives compounder weights the solution to
    ensure proper volumes and flushes the line
    between injections to avoid incompatibility
    problems. The additives compounder must be used
    with the computer and cannot be programmed alone.

71
Administration
  • Most TPN solutions are made for administration
    through a central line.
  • This route is used because it results in
    immediate dilution of the solution being
    administered and therefore a very concentrated
    solution can be administered.
  • Administering a concentrated solution often
    allows the medical team to completely meet an
    adult patients daily nutritional needs with 2000
    to 3000 mL of TPN solution.
  • Occasionally, TPNs are administered through a
    peripheral IV line can contain same ingredient,
    but diluted to a lower osmolarity. Since the
    solution is more dilute, they do not meet al the
    patients nutritional needs. May need supplements
    for caloric intake.

72
Pediatric Parenteral Drug Administration
  • Standardization of doses is not as common in
    pediatric patients as it is in adults.
  • Their doses are usually calculated based on their
    body weight, resulting in much smaller dose than
    most adults receive.
  • The volume of solution also is limited since
    their blood volume is considerably less than that
    of an adult.
  • Intermittent doses are usually given by syringe
    through a volume control chamber or by using a
    syringe pump.

73
Quality Assurance Program
  • The ASHP technical assistance bulletin describes
    three different levels of risk for products.
  • Products are classified into one of the three
    risk levels based on
  • - How they are prepared
  • - How long they can be stored
  • - whether they are prepared for a single patient
    or as part
  • of a batch, whether they are from a
    sterile or non-sterile
  • source.

74
Characteristics of Risk Levels
  • Risk Level 1
  • - Sterile products w/o preservatives for
    individual patients
  • or batch prepared with preservatives for
    multiple patients.
  • - These are sterile products transferred into a
    sterile
  • container (e.g. syringe, IV bag or
    bottle).
  • - Storage time for these products, including
    administration
  • time, should not exceed 28 hours at room
    temperature,
  • 7 days under refrigeration, or 30 days if
    frozen.

75
Characteristics continued
  • Risk Level II
  • - These products are batch-prepared w/o
    preservatives for
  • multiple patients.
  • - These include products that require multiple
    sterile ingredients
  • that are combined in a sterile container
    through a closed system
  • transfer that are then subdivided into multiple
    parts.
  • - Storage time for these products, including
    administration time,
  • can exceed 28 hours at room temperature, 7 days
    under
  • refrigeration, or 30 day frozen.

76
Characteristics continued
  • Risk Level III
  • - These products are compounded from nonsterile
  • ingredients, containers or equipment or
    prepared from
  • sterile or nonsterile ingredients in an
    open system.
  • The pharmacist is likely to be responsible for
    ensuring compliance with the guidelines and other
    standards of practice.
  • Areas of the document that affect the technician
    include training, policies and procedures, garb,
    aseptic technique, process validation, and
    end-product evaluation.

77
Process Validation
  • Means procedures that ensure that the processes
    used in sterile product preparation consistently
    result in sterile products of acceptable quality.
  • For most aseptic processes, validation is
    actually a method for evaluating the aseptic
    technique of personnel.
  • Validation may be accomplished through process
    simulation.
  • Process simulation is carried out just like a
    normal sterile product preparation process except
    that a microbial growth medium is substituted fro
    the products that would normally be used.

78
Process Validation continued
  • Once the sterile product is prepared, the growth
    medium is incubated and evaluated for microbial
    growth over a period of time.
  • No microbial growth indicates that the person
    performing the preparation did not contaminated
    the product.
  • Individuals should complete a process validation
    program before being allowed to prepare sterile
    products, and technique should be re-evaluated
    regularly.

79
End-Product Evaluation
  • End-product evaluation is the final inspection
    made by the pharmacist before the product is
    allowed to leave the pharmacy.
  • It includes an inspection for leaks, cloudiness,
    particulate matter, color, solution volume, and
    container integrity.
  • The pharmacist also verifies compounding accuracy
    with respect to the correct ingredients and
    quantities.
  • This check of the technicians work is an
    important step in ensuring that only quality
    products are sent for patient use.
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